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Combitube

The Combitube, also known as the , is a disposable, dual-lumen supraglottic airway device designed for rapid emergency insertion to secure in patients with difficult or compromised airways, particularly when traditional endotracheal is not feasible. It features a single outer tube with an internal partition creating two lumens—one for primary esophageal with side holes in the pharyngeal , and another for potential tracheal use—along with proximal oropharyngeal and distal esophageal/tracheal balloons that inflate to create seals and prevent aspiration or air leakage. The device allows blind insertion without , typically entering the in about 95% of cases, where occurs through the pharyngeal holes while the distal lumen decompresses the . Developed starting in 1981 by Austrian anesthesiologist Michael Frass, engineer Jonas Zahler, and anesthesiologist Reinhard Frenzer at the to address gaps in prehospital , the Combitube was patented in 1987 and entered commercial production in 1988 by Sheridan Catheter Corporation (later acquired by Tyco Healthcare, now part of via ). It gained widespread adoption in (EMS) worldwide for its simplicity and high success rate in non-surgical settings, serving as a bridge between basic maneuvers like bag-valve-mask ventilation and advanced techniques. Over three decades of use, it has been particularly valued in out-of-hospital cardiac arrests, , and "cannot intubate, cannot ventilate" scenarios, with studies confirming its effectiveness as a salvage airway in rapid sequence protocols. While its use has declined in favor of newer supraglottic devices as of 2025, it remains available and effective in specific emergency contexts. Key indications include supraglottic obstructions, maxillofacial or cervical spine injuries, and situations requiring immediate oxygenation without , though it is not intended as a long-term solution and requires confirmation of placement via or . While complications such as esophageal or regurgitation can occur, clinical reviews highlight its reliability in high-acuity environments, influencing the evolution of later supraglottic devices such as the and King LT.

History and Development

Invention

The Combitube, also known as the esophageal tracheal Combitube (ETC), was invented in the early 1980s by Michael Frass, Jonas Zahler, and Reinhard Frenzer at the . The primary motivation was to create a reliable emergency airway device for prehospital and (CPR) scenarios, where traditional endotracheal often required skilled personnel, specialized equipment like a laryngoscope, and optimal patient positioning—conditions frequently unavailable in the field. This design addressed limitations of existing alternatives, such as the bag-valve-mask (which risked gastric insufflation and ) and the esophageal obturator airway (which had ventilation inconsistencies), by enabling blind oral insertion and effective ventilation regardless of placement. Development began in 1981 when and Zahler initiated the concept, with Frenzer joining in 1983 to refine the prototype. The core innovation was a dual- structure: a longer esophageal for gastric drainage and via a shorter tracheal when misplaced, or direct tracheal when correctly placed, sealed by pharyngeal and esophageal balloons to prevent air leaks. Initial testing focused on functionality in animal models to assess efficacy during CPR simulations, confirming the device's ability to maintain oxygenation in both placement scenarios. The first formal publication on the Combitube appeared in 1987, authored by Frass and colleagues, detailing preliminary results from cadaver and early human trials that demonstrated comparable arterial oxygenation to endotracheal during CPR. A related that year further evaluated its use in , reporting successful in animal and human subjects. In 1987, the inventors received U.S. No. 4,688,568 for the device. Commercial production commenced in 1988 under Sheridan Catheter Corporation, later acquired by Tyco Healthcare (now part of ), with Frass retaining patent rights and receiving royalties.

Clinical Introduction and Evolution

The first human uses and clinical trials of the Combitube occurred in 1988, with initial evaluations demonstrating its effectiveness in (CPR) scenarios, achieving successful ventilation in the majority of cases through esophageal placement and comparable blood gas results to endotracheal . Published in the , these early studies highlighted the device's prompt insertion, with mean times around 18 seconds in applicable patients, and underscored its potential as a blind-insertion alternative for emergency during . The Combitube received FDA approval in the United States in as a Class II medical device specifically for emergency airway management, marking its formal entry into clinical practice and enabling widespread adoption in prehospital and hospital settings. Subsequent evolution included the introduction of the Small Adult Combitube version in 1997, designed for patients shorter than 155 cm to improve fit and reduce complications in smaller adults, expanding its applicability beyond the standard size. Manufacturer transitions shaped its ongoing development, beginning with Sheridan Catheter Corp. and moving to Tyco Healthcare in the late 1990s, followed by the spin-off to in 2007 and acquisition by in 2015, during which updates emphasized single-use disposable materials to minimize infection risks associated with reuse. By the 2010s, the Combitube's prominence declined with the rise of video and newer supraglottic airway devices offering improved visualization and success rates, though it remains incorporated in some (EMS) protocols for difficult airways.

Design and Specifications

Components

The Combitube features a dual-lumen design constructed from polyvinyl chloride (PVC), making it latex-free for use in emergency airway management. The primary lumen, which is the larger blue tube (numbered #1), is intended for esophageal placement; its distal end is sealed, but it includes eight perforations located between the two cuffs to allow ventilation into the pharynx and oxygenation when the device is positioned in the esophagus. The secondary lumen, a smaller clear or transparent tube (numbered #2), has an open distal end for direct tracheal ventilation if the device is inadvertently placed in the trachea, and it also permits gastric suctioning via a compatible catheter in cases of esophageal intubation. The device incorporates two inflatable cuffs to secure its position and prevent . The proximal pharyngeal cuff, a larger located in the midsection, seals the oropharynx and is inflated with approximately 85 mL of air for the 37 size or 100 mL for the 41 size using a pilot connected to port #1. The distal cuff, positioned at the lower end, seals the (or trachea if misplaced) and requires about 10–15 mL of air for inflation via a white pilot balloon at port #2. These ports are color-coded for quick identification: for the pharyngeal cuff and white for the distal cuff. Both lumens terminate at the proximal end with standard 15-mm universal connectors angled for easy attachment to a bag-valve-mask system. Additionally, the Combitube includes radiopaque lines along its length to facilitate radiographic confirmation of placement. Black alignment rings on the external surface aid in determining proper insertion depth relative to the teeth.

Available Sizes

The Combitube is available in two primary sizes designed for adult patients, differentiated by external diameter in French gauge (Fr) units and tailored to body height to ensure proper fit and sealing. The standard adult size, designated 41 Fr, is intended for patients taller than 152 cm (5 feet). This model features a pharyngeal (oropharyngeal) cuff with a maximum inflation volume of 100 ml and a distal cuff volume of 15 ml. The small adult size, 37 Fr, accommodates patients between 122 cm and 168 cm (4 feet to 5 feet 6 inches) in height, such as smaller women or elderly individuals, with a pharyngeal cuff volume of 85 ml and a distal cuff volume of 12 ml. No dedicated pediatric sizes are available; the 37 Fr small adult size is suitable for children taller than 122 cm (4 feet). These sizes reflect the device's double-lumen construction, where the external influences overall compatibility with patient , while cuff volumes ensure of the or trachea depending on placement. The 41 Fr model's larger dimensions provide robust sealing for taller patients, whereas the 37 Fr variant offers a more proportionate fit for shorter statures to minimize tissue trauma. Both sizes include color-coded : the longer blue lumen (#1) for primary esophageal placement and via pharyngeal perforations, and the shorter clear lumen (#2) for potential tracheal or gastric . All Combitube models are single-use and supplied sterile to prevent cross-contamination, packaged in trays or roll-up kits that include a for pharyngeal inflation, a for the distal , and a for gastric decompression. They feature a universal 15 mm connector at the proximal end for compatibility with standard ventilators, Ambu bags, or other respiratory equipment.

Indications and Contraindications

Primary Indications

The Combitube is primarily indicated for securing the airway in prehospital settings involving unconscious patients without a gag reflex, such as those experiencing or where rapid is essential to facilitate and oxygenation. In these scenarios, its blind insertion capability allows for quick deployment by personnel at accident sites or during transport, particularly when patient access is restricted. It serves as a key tool in difficult airway situations, including cases of failed orotracheal intubation attempts or limited access due to factors like cervical spine immobilization in trauma patients. The device is recommended when conventional is challenging or impossible, such as in "cannot intubate, cannot ventilate" emergencies, providing an effective rescue option to maintain oxygenation. During (CPR), the Combitube enables blind insertion and effective ventilation without interrupting chest compressions, aligning with (AHA) guidelines for advanced providers in management. Supraglottic airways are considered an acceptable alternative to endotracheal ( 2b recommendation in 2020 AHA guidelines), allowing for 10 breaths per minute while compressions continue at 100-120 per minute. In resource-limited environments, such as or field medicine, the Combitube supports short-term and airway control for unconscious or paralyzed patients, where advanced equipment may be unavailable. Its simplicity makes it suitable for use by combat medics or in austere settings requiring rapid intervention. The device is particularly indicated for adults and small adults in out-of-hospital , with esophageal placement success rates exceeding 95%, enabling reliable ventilation even if tracheal positioning is not achieved.

Contraindications

The Combitube is contraindicated in patients with an intact gag reflex, as insertion may provoke and aspiration. Known or suspected esophageal pathology represents an absolute , including conditions such as strictures, tumors, , diverticula, or recent esophageal or gastric surgery, due to the risk of or exacerbation of the underlying . of substances is also an absolute , as it may lead to esophageal damage that complicates safe placement and increases the risk of rupture. Suspected upper airway obstruction or further prohibits use, as the device's design assumes a patent esophageal or tracheal pathway for proper positioning. Relative contraindications include patients with heights under 4 feet (122 cm) or over 6 feet 6 inches (198 cm), owing to anatomical mismatch with available sizes that may prevent secure fit or effective sealing. The device is not indicated for pediatric patients under approximately 48 inches (122 ) in height, as no suitable sizes exist and anatomical proportions differ significantly. Prolonged exceeding 8 hours is relatively contraindicated due to risks of pharyngeal mucosal ischemia from pressure. Pre-insertion should screen for of or esophageal abnormalities to avoid misplacement, and the device is generally avoided in awake or responsive patients where alternatives like endotracheal are feasible.

Insertion and Use

Procedure Steps

The insertion of the Combitube, an esophageal-tracheal double-lumen airway device, follows a standardized blind technique to establish ventilation in emergency settings where traditional intubation is challenging. Preparation: Position the patient supine on a firm surface. If cervical spine injury is not suspected, extend the head into the sniffing position by elevating the occiput with towels or padding to align the oral, pharyngeal, and tracheal axes. Select the appropriate size—37 Fr for patients 122–168 cm (4' to 5'6") tall or 41 Fr for those ≥170 cm (5'7") tall—and test both cuffs for leaks by inflating and deflating them. Lubricate the distal tip and outer surface of the deflated device with sterile, water-soluble lubricant to facilitate smooth passage. Ensure suction equipment is immediately available to manage potential secretions or regurgitation. Insertion: Open the patient's mouth using a jaw-thrust or chin-lift maneuver while maintaining inline stabilization if is possible. Grasp the and lower with the non-dominant hand to displace the forward. With the dominant hand, insert the Combitube blindly into the midline of the oropharynx, directing it posteriorly along the natural curve of the toward the ; avoid using force or a laryngoscope. Advance the gently until the two straddle the upper teeth or alveolar ridge, ensuring proper depth without over-insertion. Cuff Inflation: First, inflate the proximal pharyngeal (connected via the blue pilot , Line 1) with 85 mL of air for the 37 size or 100 mL for the 41 size using a large-volume , or until a seal is achieved without audible leak during a test . Then, inflate the distal (connected via the white pilot , Line 2) with 12 mL of air for the 37 size or 15 mL for the 41 size using a small to occlude the distal airway. Initial Ventilation: Attach a bag-valve-mask or to the primary (longer blue , No. 1), which assumes esophageal placement, and deliver initial breaths at 8–10 per minute with 500–800 mL . Observe for chest rise; if absent or epigastric distension occurs, immediately deflate both cuffs, withdraw the 1–2 cm, and reattempt insertion, or switch to ventilating through the secondary (shorter clear , No. 2) for presumed tracheal placement. The dual- design allows this switch without removal. Securing: Once effective ventilation is established, secure the tube in place using , a commercial holder, or ties around the head to prevent dislodgement. Continuously monitor for tube migration, especially during patient transport or movement.

Ventilation and Confirmation

Following insertion of the Combitube, proper placement must be verified to ensure effective ventilation. Initial confirmation involves auscultation of bilateral breath sounds over the lung fields and absence of epigastric sounds to distinguish tracheal from esophageal positioning, though auscultation can be challenging due to the device's design. A colorimetric carbon dioxide detector attached to the ventilation lumen provides reliable verification: a color change from yellow to purple indicates tracheal placement with exhaled CO2 detection, while no change suggests esophageal placement. In approximately 95% of cases, the Combitube distal tip enters the , allowing through the primary (numbered #1, typically marked blue) via multiple pharyngeal perforations proximal to the distal , which directs to the trachea while the blind-ended secondary (#2) seals the . In the rarer tracheal placement (about 5%), occurs directly through the secondary (#2) as with a conventional endotracheal tube, bypassing the pharyngeal ports. is performed using a bag-valve device at 8-10 breaths per minute, with tidal volumes of approximately 500 mL per breath lasting about 1 second. Ongoing monitoring includes continuous waveform if available to track end-tidal CO2 levels and confirm sustained tracheal patency, alongside observation of symmetric chest rise and . A chest serves as definitive confirmation, visualizing the distal tip in the trachea for tracheal placement or in the for esophageal placement. For gastric in esophageal placement, a nasogastric tube can be inserted through the primary to aspirate contents and reduce risk. The Combitube should be removed once a definitive airway, such as an endotracheal tube, can be secured by appropriately trained personnel, or if complications occur; it is not intended for prolonged use beyond several hours. Removal involves deflating the pharyngeal (proximal) first, followed by the distal , then gently withdrawing the device while maintaining oxygenation, often with ready to manage any secretions.

Complications and Management

Common Complications

One of the most frequent complications associated with the Combitube is , occurring in 39-48% of patients due to the pressure from the inflated pharyngeal cuff on the oropharyngeal structures. This discomfort typically manifests postoperatively and is often accompanied by , reported in up to 68% of cases from similar mucosal irritation. These symptoms generally resolve within several days with , including oral analgesics, , and avoidance of irritants, though severe cases may persist longer. Upper airway hematoma or mucosal lacerations arise from mechanical during blind insertion, with evidence of blood on the device noted in approximately 31% of uses and overt in up to 36% in smaller cohorts. Patients should be monitored for signs of swelling or airway compromise, managed with ice application, analgesics, and observation; most resolve without intervention within days. Vomiting or regurgitation poses a particularly in semi-conscious patients during insertion, potentially leading to if not addressed promptly. Preemptive suctioning of oropharyngeal contents and immediate inflation of the cuffs upon placement minimize this by sealing the airway. Overinflation of the cuffs, if exceeding manufacturer recommendations (typically 85-100 mL for the pharyngeal and 10-15 mL for the distal ), can cause local ischemia by impairing mucosal , with symptoms such as persistent hoarseness or observed in 12-17% of cases. Adhering to specified volumes and monitoring pressure when possible prevents these issues, which usually abate upon deflation. Overall, minor complications occur in 20-40% of Combitube insertions, a rate higher than with endotracheal tubes in short-term applications, as evidenced by comparative studies showing elevated pharyngeal trauma.

Rare but Serious Risks

Although esophageal perforation is a rare complication of Combitube insertion, with an incidence of less than 1% (approximately 0.7% in a prehospital series of 280 patients), it is more likely to occur in patients with preexisting esophageal pathology or trauma. This injury typically presents with severe neck or chest pain, subcutaneous emphysema, and signs of mediastinitis, necessitating immediate surgical consultation, broad-spectrum antibiotics, and potential endoscopic or operative repair. Aspiration pneumonia associated with the Combitube occurs in up to 11% of prehospital cases, often due to device misplacement allowing regurgitation or gastric contents to enter the airway. Prevention strategies include applying during insertion, while management involves patient positioning to facilitate drainage, aggressive suctioning, and supportive antibiotics if infection develops. Cranial nerve dysfunction, such as transient vocal cord or palsy, represents a rare neuropraxia potentially caused by prolonged cuff or pharyngeal trauma during Combitube use. These injuries typically manifest as dysphonia, , or tongue deviation postoperatively and are managed through neurological monitoring, with most cases resolving spontaneously within weeks without long-term intervention. Pneumothorax may arise infrequently (around 2% incidence in prehospital use) from high-pressure if the Combitube is inadvertently placed in the trachea, leading to . Diagnosis relies on clinical for absent breath sounds and confirmation via chest , with treatment involving immediate via needle thoracostomy or chest tube insertion if tension physiology is present. Esophageal rupture has been reported in cases from the late 1990s following Combitube use, often requiring endoscopic dilation or surgical management if long-term complications develop. While complications persist, the device's use has decreased with advancements in as of 2023.

Comparisons with Other Airway Devices

Versus Endotracheal Tube

The Combitube offers advantages in insertion speed and success rates compared to the standard endotracheal tube (ETT), particularly in settings or among less experienced providers. Blind insertion of the Combitube typically achieves airway securing in 15-40 seconds with first-attempt success rates of 90-100%, even for novices after brief training. In contrast, ETT placement requires and often takes 30-90 seconds, with first-attempt success rates of 70-90% in skilled hands, dropping lower for paramedics or emergency medical staff without extensive practice. These differences make the Combitube a faster alternative for rapid in out-of-hospital or scenarios. Regarding protection against , the ETT provides superior sealing via its positioned below the , minimizing regurgitation risk during positive pressure . The Combitube relies on its pharyngeal and esophageal for gastric and partial barrier function, but studies indicate a higher potential for regurgitation and compared to ETT, though it still reduces risk relative to basic airways. Training requirements for the Combitube are minimal, often limited to 1-2 hours of instruction for personnel, enabling high success among paramedics and nurses without advanced expertise. ETT insertion, however, demands specialized skills and ongoing simulation practice, typically reserved for anesthesiologists or highly trained intensivists. The Combitube is intended for short-term use, generally under 2 hours as an interim device before definitive airway placement, due to concerns over prolonged and . In comparison, the ETT supports extended for hours or days in intensive care settings. Cost-wise, the disposable Combitube unit ranges from $50-80, including necessary syringes and adapters, while a basic ETT tube costs $3-10 but requires additional equipment like a laryngoscope ($200-500) and blades, increasing overall setup expenses.

Versus Supraglottic Devices

The Combitube, a dual-lumen esophageal-tracheal supraglottic airway device, differs in anatomical positioning and mechanism of action from other supraglottic devices like the (LMA). While the LMA creates a supraglottic seal above the to facilitate without entering the trachea or , the Combitube is designed for blind insertion that typically results in esophageal placement (about 95% of cases), with directed through a distal tracheal lumen or, less commonly, reversed if tracheal placement occurs. This invasive dual-path approach allows the Combitube to provide effective in scenarios where visualization is challenging, such as during (CPR), where it can be inserted with minimal interruption to chest compressions, unlike some supraglottic devices that may require head repositioning. In terms of success rates for difficult airways, particularly in trauma settings, the Combitube demonstrates high efficacy, with insertion success reaching 95.1% as a salvage device following failed orotracheal intubation in prehospital trauma patients. Comparatively, the LMA achieves success rates of 85-90% in difficult airway scenarios, though it can drop to as low as 50% among less experienced emergency medical technicians. However, the LMA generally allows for faster placement, with median insertion times of 40 seconds in unskilled hands versus 45 seconds for the Combitube, and even quicker in manikin simulations (5-6 seconds for both, with LMA slightly slower for novices); this speed advantage makes the LMA less traumatic overall during insertion. Regarding gastric access and aspiration risk, the Combitube's esophageal positioning enables direct through its proximal , preventing gastric and in up to % of cases, offering superior protection compared to LMAs, which provide limited safeguards against regurgitation. Certain LMA variants, such as the ProSeal, include a dedicated gastric tube port for , but this is less comprehensive than the Combitube's built-in esophageal venting. Both devices are suitable for short-term , yet the Combitube is particularly favored in situations due to its robust aspiration barrier and reliability in low-flow environments. The complication profile of the Combitube includes a higher incidence of injuries, such as pharyngeal (10-20% in some reports), compared to the LMA's lower rate (around 5%, primarily or minor leaks). Studies from the , including manikin-based trials, indicate similar oxygenation and between the two devices in settings, with both achieving near-100% success in skilled hands; however, the Combitube shows superiority in low-skill or inexperienced users due to its forgiving design, which permits regardless of exact placement. The Combitube has influenced later supraglottic devices such as the King LT, which features a single inflation port for both cuffs and a simpler design. Studies show the King LT achieves faster insertion times (around 24 seconds versus 38 seconds for the Combitube) and is perceived as easier to use by flight crews and paramedics, with similar high success rates (96-100%), though both devices carry risks of . The King LT has largely replaced the Combitube in some protocols due to these advantages.

Current Status and Guidelines

Evidence from Studies

Early clinical trials by Frass and colleagues from 1988 to 1995 established the Combitube's efficacy for emergency during CPR. In a 1988 study involving 50 patients, the device provided effective with blood gas analyses comparable to endotracheal , achieving success in all applicable cases. A 1993 prospective study further demonstrated that ICU nurses achieved successful and with the Combitube in CPR scenarios at rates equivalent to endotracheal by intensivists, with high reliability across over 100 patients. Prehospital studies in the 2000s highlighted the Combitube's utility in for . A 2000 multicenter trial involving EMT-defibrillation providers reported successful airway placement in 92% of 195 cardiorespiratory arrest cases, enabling effective without significant delays. Similarly, a 2002 study across 831 adult patients showed a 95.4% insertion success rate, with outcomes supporting its role in out-of-hospital settings comparable to advanced airways. These findings indicated improved to hospital admission in select cohorts using the Combitube versus basic bag-mask , though direct comparative data varied by protocol. Research focused on complications has identified risks associated with Combitube use, particularly in prehospital environments. A 2007 retrospective analysis of 281 cases reported serious adverse events, such as esophageal and upper airway , in 4.3% of instances, with higher rates linked to esophageal or difficult insertions. A 2003 synthesized over 200 reported cases, noting an overall incidence of major complications around 8%, including and nerve injuries, emphasizing the need for careful patient selection. Comparative randomized controlled trials have evaluated the Combitube against , especially among novices. A 2015 manikin-based RCT involving inexperienced emergency staff found the Combitube achieved 100% airway success versus 73% for (p=0.0001), with significantly faster insertion times (median 5 seconds versus longer for endotracheal tube) while maintaining equivalent oxygenation levels. Recent meta-analyses of supraglottic airway devices, including the Combitube, in out-of-hospital have shown benefits in procedural efficiency but limited impact on outcomes. A 2024 and indicated that supraglottic devices reduce no-flow time during CPR compared to by minimizing interruptions for placement, yet they confer no significant mortality benefit over alternatives like bag-mask ventilation, with pooled short-term survival odds ratios near 1.0.

Recommendations in Practice

The () 2025 guidelines position supraglottic airway devices (SGAs), including legacy devices like the Combitube, as viable alternatives to endotracheal for during when performed by trained providers, particularly after failed basic attempts or in systems with low intubation success rates. These guidelines recommend assessing and considering placement of an advanced airway device, such as an endotracheal tube or supraglottic device, with confirmation via to verify placement and monitor end-tidal CO2. The European Resuscitation Council (ERC) 2025 guidelines similarly endorse SGAs as a second-line option following bag-mask ventilation during , with a preference for the i-gel over laryngeal tubes when using an SGA. The Combitube is not explicitly prioritized over newer SGAs, and permanent end-tidal CO2 measurement is mandatory for verification. The National Association of EMS Physicians (NAEMSP) 2022 position statement on prehospital supraglottic airways endorses SGAs, such as the Combitube, for use in (EMS) during difficult or failed airways, emphasizing their role in providing oxygenation and ventilation while minimizing interruptions in chest compressions. NAEMSP advocates for agency-specific protocols that include SGA deployment after unsuccessful attempts, with requirements ensuring providers achieve proficiency through supervised simulations and a minimum of 10 successful insertions on manikins prior to independent use. Annual recertification via high-fidelity simulation is recommended to maintain skills, focusing on placement verification techniques like , chest rise observation, and . Despite these endorsements, the Combitube faces limitations in contemporary protocols; it is not considered first-line in settings equipped with video laryngoscopes, where visualization techniques are preferred for superior success rates in non-arrest scenarios. Manufacturer discontinuation of the Combitube has restricted its availability, though it remains in use in some systems as of 2025, prompting transitions to updated alternatives. Looking ahead, integration of is now mandatory in major guidelines for all advanced airway confirmations, including legacy SGAs like the Combitube where still in use, to reduce unrecognized malposition.

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