AzTrials
AzTrials

Endoscopy, GastrointestinalNCT07182786

The Efficacy of Laryngeal Mask Airway Gastro (LMA® Gastro™) in Preventing Hypercarbia in ERCP Patients

A study testing LMA Gastro in people with Endoscopy, Gastrointestinal and Procedural Sedation, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 45 years
What is being tested?
LMA Gastro
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Oct 2024to 15 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients age: 20-45 years
  • ASA classification: II and III
  • Body mass index: 25 -30 kg/m2
  • Height > 155 cm
  • ERCP procedures of difficulty grade II and III (according to American Society of Gastroenterologists ASGE grading system for ERCP procedures).

Who cannot join

  • Anticipated difficult airway
  • Restricted head and neck mobility
  • Pulmonary disease
  • Obese Patients with a BMI of ≥ 35 kg/m2
  • Patients with moderate to severe ascites
  • Patients with Childe-Pughe-Turcotte (CPT) classification C
Show all 11Show fewer
  • Increased risk of aspiration (for example incomplete fasting hours, delayed gastric emptying, gastric outlet obstruction, etc.)
  • ERCP procedures of difficulty grade I (due to relatively short procedure duration)
  • ERCP procedures of malignant obstructive jaundice
  • ERCP procedures less than 30 minutes and more than 120 minutes.
  • Patient refusal

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Theodor Bilharz Research Institute

    Giza, 12411

Other trials in Egypt

About this study

Official title: The Efficacy of Laryngeal Mask Airway Gastro (LMA® Gastro™) in Preventing Hypercarbia in ERCP Patients: A Randomized Controlled Study

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.

Read the detailed description

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.

Being tested
LMA Gastro
Keywords
ERCP anesthesia, Anesthesia for endoscopy, LMA Gastro, Hypercarbia
Medical subject headings
Hypercapnia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LMA GastroDevice

    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.

Study groups in NCT07182786
Study groupRoleWhat they receive
LMA Gastro group (L group): total intravenous anesthesia and LMA GastroActive comparatorNot described
Receives: Device: LMA Gastro
Control group (C group): total intravenous anesthesia with no airway device , with Nasal Cannula.No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. End tidal CO2

    End tidal CO2 measurement after 30 minutes of procedure time. It is measured by capnography in patients undergoing ERCP procedure.

    Measured: 30 minutes from induction of Anesthesia

Secondary outcomes (18)
  1. Hypercarbia

    ETCO2 (≥45 mmHg) or PaCO2(≥50 mmHg) or both Highest ETCO2 and PaCO2 recorded during procedure

    Measured: Procedures of duration between 30 and 120 minutes

  2. Timing of Hypercarbia

    Time till ETCO2 (≥45 mmHg) or PaCO2(≥50 mmHg) or both

    Measured: Procedures of duration between 30 and 120 minutes

  3. Hypoxia

    Lowest SpO2 and PaO2 recorded during procedure

    Measured: Procedures of duration between 30 and 120 minutes.

  4. Number of Hypoxic episodes

    Number of hypoxic episodes (desaturation to SPO2 of 92% or below for at least 15 seconds)

    Measured: Procedures of duration between 30 and 120 minutes

  5. Hemodynamic stress response : Heart Rate

    Heart rate

    Measured: Procedures of duration between 30 and 120 minutes.

  6. Hemodynamic stress response : Mean arterial blood pressure

    Mean arterial blood pressure

    Measured: Procedures of duration between 30 and 120 minutes.

  7. 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).

    Measured: From Anesthesia induction till start of procedure

  8. Efficiency of LMA gastro in anesthesia of ERCP procedures: Ease of duodenoscope introduction.

    Number of attempts of ERCP duodenoscope introduction

    Measured: From induction of Anesthesia till start of procedure

  9. Efficiency of LMA gastro in anesthesia of ERCP procedures: ease of LMA Gastro insertion.

    Number of attempts of LMA Gastro insertion

    Measured: From induction of Anesthesia till start of procedure

  10. Efficiency of LMA gastro in anesthesia of ERCP procedures: Safety of LMA Gastro

    Number of displacements of LMA Gastro and need for repositioning

    Measured: During whole ERCP procedure

  11. 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

    Measured: whole duration of ERCP procedure

  12. Efficiency of LMA gastro in anesthesia of ERCP procedures: Recovery time

    Recovery time (from stopping propofol infusion till discharge to PACU)

    Measured: from the end of ERCP procedure till discharge to PACU

  13. Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure failure

    Number of failed procedures in both groups

    Measured: procedures between 30 and 120 minutes

  14. 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

    Measured: procedures between 30 and 120 minutes

  15. Efficiency of LMA gastro in anesthesia of ERCP procedures: post operative complications

    occurrence of post operative Nausea, vomiting or sore throat

    Measured: From end of procedure till discharge from PACU (after 30 min.)

  16. 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

    Measured: procedures between 30 and 120 minutes

  17. 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

    Measured: procedures between 30 and 120 minutes

  18. 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.

    Measured: procedures between 30 and 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start1 Oct 2024
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182786
Sponsor's protocol ID
MD-507-2023
Status last verified
Sep 2025
First submitted
5 Sep 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing LMA Gastro in people with Endoscopy, Gastrointestinal and Procedural Sedation, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

End tidal CO2 (time frame: 30 minutes from induction of Anesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in