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.
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
- Conditions the study is for
- Endoscopy, Gastrointestinal, Procedural Sedation, Anesthesia Airway Management
- 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.
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.
- Conditions
- Endoscopy, Gastrointestinal, Procedural Sedation, Anesthesia Airway Management, Anesthesia for Endoscopic Procedures
- 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 group | Role | What they receive |
|---|---|---|
| LMA Gastro group (L group): total intravenous anesthesia and LMA Gastro | Active comparator | Not described Receives: Device: LMA Gastro |
| Control group (C group): total intravenous anesthesia with no airway device , with Nasal Cannula. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Timing of Hypercarbia
Time till ETCO2 (≥45 mmHg) or PaCO2(≥50 mmHg) or both
Measured: Procedures of duration between 30 and 120 minutes
Hypoxia
Lowest SpO2 and PaO2 recorded during procedure
Measured: 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)
Measured: Procedures of duration between 30 and 120 minutes
Hemodynamic stress response : Heart Rate
Heart rate
Measured: Procedures of duration between 30 and 120 minutes.
Hemodynamic stress response : Mean arterial blood pressure
Mean arterial blood pressure
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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.
- First posted19 Sep 2025
- Study start1 Oct 2024
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopy, GastrointestinalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Responsible party
- Principal investigator, Karim Mohamed Aly Ahmed, Theodor Bilharz Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Laryngeal Mask Airway Gastro (LMA® Gastro™) in Preventing Hypercarbia in ERCP Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07182786
- Acronym / sponsor ID
- MD-507-2023
- Conditions
- Endoscopy, Gastrointestinal, Procedural Sedation, Anesthesia Airway Management, Anesthesia for Endoscopic Procedures
- Keywords
- ERCP anesthesia, Anesthesia for endoscopy, LMA Gastro, Hypercarbia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Gastro group (L group): total intravenous anesthesia and LMA Gastro | Active comparator | Device: LMA Gastro |
| Control group (C group): total intravenous anesthesia with no airway device , with Nasal Cannula. | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA GastroLMA 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. | Device | LMA Gastro group (L group): total intravenous anesthesia and LMA Gastro |
Primary outcome
End tidal CO2
Time frame: 30 minutes from induction of Anesthesia
End tidal CO2 measurement after 30 minutes of procedure time. It is measured by capnography in patients undergoing ERCP procedure.
18 secondary outcomes
Hypercarbia
Time frame: Procedures of duration between 30 and 120 minutes
Timing of Hypercarbia
Time frame: Procedures of duration between 30 and 120 minutes
Hypoxia
Time frame: Procedures of duration between 30 and 120 minutes.
Number of Hypoxic episodes
Time frame: Procedures of duration between 30 and 120 minutes
Hemodynamic stress response : Heart Rate
Time frame: Procedures of duration between 30 and 120 minutes.
Hemodynamic stress response : 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.
Time frame: From Anesthesia induction till start of procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Ease of 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.
Time frame: From induction of Anesthesia till start of procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Safety of LMA Gastro
Time frame: During whole ERCP procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Anesthetic consumption of propofol
Time frame: whole duration of ERCP procedure
Efficiency of LMA gastro in anesthesia of ERCP procedures: Recovery time
Time frame: from the end of ERCP procedure till discharge to PACU
Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure failure
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: procedure duration
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: post operative complications
Time frame: From end of procedure till discharge from PACU (after 30 min.)
Efficiency of LMA gastro in anesthesia of ERCP procedures: operator satisfaction
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: anesthesiologist satisfaction
Time frame: procedures between 30 and 120 minutes
Efficiency of LMA gastro in anesthesia of ERCP procedures: conversion to endotracheal intubation.
Time frame: procedures between 30 and 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.