An interventional study of LMA Gastro in Endoscopy, Gastrointestinal, Procedural Sedation and Anesthesia Airway Management, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
Endoscopic retrograde cholangiopancreatography (ERCP) has evolved into a primarily therapeutic procedure that often requires anesthetic support. While moderate to deep sedation is commonly used, it carries a high risk of respiratory complications, including hypoxemia and hypercapnia, which can lead to cardiovascular instability. General anesthesia with endotracheal intubation offers greater airway protection but is associated with hemodynamic stress, the need for neuromuscular blockade, longer recovery, and potential airway trauma.
The LMA® Gastro™ Airway, introduced in 2017, was specifically designed for upper gastrointestinal endoscopy. It combines a supraglottic airway with a dedicated channel for the endoscope, enabling ventilation and airway protection while facilitating the procedure. Early studies demonstrate high success rates for both airway management and ERCP completion, with a low incidence of adverse events. However, most available evidence is observational, and randomized controlled trials are needed to establish its effectiveness compared with traditional sedation and general anesthesia with intubation.
In conclusion, the LMA Gastro shows promise as a safe and efficient alternative airway device for ERCP, potentially bridging the gap between deep sedation and invasive intubation, though further evidence is required to confirm its impact on respiratory and hemodynamic outcomes.
Endoscopic retrograde cholangiopancreatography (ERCP) is fast emerging as a therapeutic procedure rather than a diagnostic one, requiring anesthetic support for successful completion of the procedure. The procedure can be uncomfortable especially due to prone positioning, multiple passages of endoscope, air insufflations, dilatation of ductal structures and prolonged duration which requires a high degree of cooperation from patients. A large number of patients need to be given general anesthesia (GA), in order to minimize incidence of adverse respiratory and hemodynamic events in the peri-procedure period. The use of GA with endotracheal intubation (ETT) or supraglottic devices protects the airway, reduces ERCP failure and complication rates. However, ETT involves rigid laryngoscopy with consequent undesirable hemodynamic responses and use of neuromuscular blocking drugs. It also has the disadvantage of a longer recovery time and possibility of injury to the oro-pharynx at insertion.
Moderate to deep sedation is a commonly employed technique for ERCPs, with general anesthesia utilizing an endotracheal intubation being reserved for selected cases. Reported rates of hypoxemia during all endoscopic procedures range from 11 to 50%, and this may be as high as 60% with ERCP. Sustained hypoxia is a major risk factor for peri-procedural cardiac arrhythmias and myocardial ischemia. Respiratory complications that occur during intravenous sedation have a higher risk of hypercapnia than hypoxemia. Patients receiving propofol-based tubeless sedation may be at higher risk of sedation-related adverse events than patients receiving GA. Moreover, when low-flow oxygen is administered through a nasal cannula, the apparent oxygen saturation value is maintained at a normal concentration; however, hypoventilation is sustained, which may result in impaired exhalation. Gradual CO₂ accumulation, and CO₂ concentrations maintained at 60 mmHg or higher, are risk factors for secondary circulatory abnormalities such as an abnormal increase in blood pressure, tachycardia, and arrhythmia.
As the number of gastrointestinal endoscopic interventions and possibilities increased, and the number of patients with severe comorbidities and existing medical conditions, the need for minimally invasive airway devices specially dedicated for endoscopic procedures became relevant. A modified laryngeal tube with a dedicated channel for an endoscope was described as an alternative airway device. This approach was further developed with the introduction of the LMA® Gastro™ Airway, a refined tool in advanced airway management for upper gastrointestinal endoscopy.
The LMA® Gastro™ Airway is a cuffed peri-laryngeal supraglottic airway (SGA) with an endoscopic channel, having a maximum diameter of 14 mm, which suits all standard endoscopes. Its design features include a channel for esophageal intubation, a separate channel with a terminal cuff for lung ventilation, and an integrated bite block and cuff pressure indicator. It comes in three available sizes: #3 (30-50 kg), #4 (50-70 kg), and #5 (70-100 kg).
This device has been reported to have a high airway insertion success rate and a high first-attempt endoscopy success rate in patients with low risk of pulmonary aspiration. Observational studies have suggested that the LMA Gastro may be a safe alternative to tubeless anesthesia in patients undergoing ERCP, though some were limited by small sample size and non-randomized design. Retrospective analyses have demonstrated high success rates of ERCP completion with well-maintained ventilation and minimal intraoperative and postoperative adverse events. However, confounding factors in patient selection and the absence of randomized controlled comparisons with conventional airway techniques remain limitations.
Although the LMA Gastro has been demonstrated in several studies as a safe and efficient substitute for general anesthesia or deep sedation tubeless anesthesia for ERCP procedures, to date there is no exact measurement or assessment of its role in prevention of hypercarbia or hypoxia.
Aim of the work:
The aim of this study is to evaluate the efficacy of using LMA Gastro in preventing hypercarbia and decreasing hypoxic and hyper carbic episodes in patients undergoing ERCP procedures of average timing and difficulty according to the ASGE (American Society of Gastroenterologists) grading system. In addition, to assess the efficiency of using the new LMA Gastro® airway device in endoscopic procedures and its stress response.
156 studies on the registry are indexed under Hypercapnia; 31 are open to participants now.
This study's enrollment of 50 is above the median of 36 across 120 interventional studies indexed under Hypercapnia.
Browse Hypercapnia studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: LMA Gastro
LMA Gastro, is a laryngeal mask airway device that is specifically designed for air way management in GIT endoscopic procedures due to having a channel dedicated for endoscope introduction. the safety and efficacy of LMA Gastro was researched in many studies, but its role in preventing Hypercarbia during ERCP procedures is yet to be researched and tested.
End tidal CO2
End tidal CO2 measurement after 30 minutes of procedure time. It is measured by capnography in patients undergoing ERCP procedure.
Time frame: 30 minutes from induction of Anesthesia
Hypercarbia
ETCO2 (≥45 mmHg) or PaCO2(≥50 mmHg) or both Highest ETCO2 and PaCO2 recorded during procedure
Time frame: Procedures of duration between 30 and 120 minutes
Timing of Hypercarbia
Time till ETCO2 (≥45 mmHg) or PaCO2(≥50 mmHg) or both
Time frame: Procedures of duration between 30 and 120 minutes
Hypoxia
Lowest SpO2 and PaO2 recorded during procedure
Time frame: Procedures of duration between 30 and 120 minutes.
Number of Hypoxic episodes
Number of hypoxic episodes (desaturation to SPO2 of 92% or below for at least 15 seconds)
Time frame: Procedures of duration between 30 and 120 minutes
Hemodynamic stress response : Heart Rate
Heart rate
Time frame: Procedures of duration between 30 and 120 minutes.
Hemodynamic stress response : Mean arterial blood pressure
Mean arterial blood pressure
Time frame: Procedures of duration between 30 and 120 minutes.
Efficiency of LMA gastro in anesthesia of ERCP procedures: duration till endoscope introduction.
Measuring time taken from induction of anesthesia till ERCP duodenoscope introduction( start of ERCP procedure).
Time frame: From Anesthesia induction till start of procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Ease of duodenoscope introduction.
Number of attempts of ERCP duodenoscope introduction
Time frame: From induction of Anesthesia till start of procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: ease of LMA Gastro insertion.
Number of attempts of LMA Gastro insertion
Time frame: From induction of Anesthesia till start of procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Safety of LMA Gastro
Number of displacements of LMA Gastro and need for repositioning
Time frame: During whole ERCP procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Anesthetic consumption of propofol
* Mean dose of propofol used in induction in both groups * Mean dose of propofol used for maintenance of anesthesia
Time frame: whole duration of ERCP procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Recovery time
Recovery time (from stopping propofol infusion till discharge to PACU)
Time frame: from the end of ERCP procedure till discharge to PACU
Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure failure
Number of failed procedures in both groups
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure duration
Effect of using LMA Gastro on average procedure duration in comparison to control group
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: post operative complications
occurrence of post operative Nausea, vomiting or sore throat
Time frame: From end of procedure till discharge from PACU (after 30 min.)
Efficiency of LMA gastro in anesthesia of ERCP procedures: operator satisfaction
The operator rates the following on a scale from 1to 5 ( 1 being worst and 5 the best): * ease of endoscope introduction * ease of manipulation and advancement * overall satisfaction
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: anesthesiologist satisfaction
The anesthesiologist rates the following on a scale from 1 to 5 ( 1 being the worst and 5 the best): * ease of LMA Gastro insertion * overall satisfaction
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: conversion to endotracheal intubation.
number of procedures that were converted to traditional endotracheal intubation due to vomiting, risk of aspiration with excessive secretions in oral cavity, severe laryngeal spasm not responding to increasing depth of anesthesia or I.V. lidocaine, airway obstruction and persistent hypoxia.
Time frame: procedures between 30 and 120 minutes
Plan to share: Undecided
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