New airway device may reduce breathing risks during ERCP
NCT ID NCT07182786
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether a special airway device called LMA Gastro can prevent high carbon dioxide levels (hypercarbia) in patients undergoing ERCP, a procedure to examine the bile and pancreatic ducts. Fifty adults aged 20-45 with mild to moderate health risks participated. The device combines a breathing tube with a channel for the endoscope, aiming to keep the airway open and reduce breathing complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LMA Gastro device
- What this could lead to
- If it works, this device could offer a safer, less invasive way to manage breathing during ERCP, reducing the risk of high CO2 levels.
- What could go wrong
- This is a small, early-stage study with only 50 participants. Results may not apply to all patients, and the device may not prevent hypercarbia better than standard methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Theodor Bilharz Research Institute
Giza, 12411, Egypt
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Other studies related to the condition(s) this trial covers.
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