Supraglottic Airway EfficiencyNCT04196582
LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
A study testing Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures. in people with Supraglottic Airway Efficiency and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration
- What is being tested?
- Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 10 Jul 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status 1-2
- Elective Procedures
- Weight 50-100 Kg
Who cannot join
- Laryngeal mask airway contraindications.
- Anesthesic drug allergies
- Height <155 cm
- Body Mass index > 35 kg/m2
- Alcohol or narcotic drug usage
- Restrictive or obstructive pulmonary diseases
Show all 14Show fewer
- Hepatic cardiac or renal failure
- Psychotic problems
- Neurologic or cognitive deficiencies.
- Pregnancy
- Difficult airway or facial deformities
- Previous cervical surgery or cervical radiotherapy
- Previous esophagus surgery
- High risk of pulmonary aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial
Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.
Read the detailed description
Supraglottic airway (SGA) devices are produced for avoiding endotracheal intubation for anesthesic interventions. Second generation SGA's like GLT and LMA® Gastro airway are using for endoscopic biliopancreatic procedures. Both of them have an airway canal and endoscopic canal. Although they can use for same reason, their designs are different. So, their airway securities, endoscopic manipulations and complications, would be different.
This study planned as single blind. American Society of Anesthesiologists (ASA) Physical status 1-2 100 patients which will be take endoscopic retrograde cholangiopancreatography (ERCP) included. The study starts after randomization and ends after discharge from the recovery room. All patients will be monitorised for hemodynamic parameters. Depth of anesthesia will be provided by bispectral index (BIS) monitoring. After anesthesia induction SGA will placed by an experienced anesthesiologist. Bilateral chest movements and auscultation, capnogram graphy and oropharyngeal leak pressure test will be used for confirmation of placement. After procedure endoscopist will take pictures of esophagus and hypopharynx. After extubation and sufficient consciousness and breathing of patient, patients will be transferred to post-anaesthesia care unit (PACU). Vital parameters will continue to monitoring in PACU. Patients will be discharge as usual with an Aldrete score ≥ 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
- Conditions
- Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration, Complication of Anesthesia, Esophagus Injury, Endoscopic Ergonomics
- Being tested
- Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.
- Keywords
- LMA gastro airway, Gastro-laryngeal tube, ERCP, airway complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.Device
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
| Study group | Role | What they receive |
|---|---|---|
| Gastro-laryngeal tube Group (Group G) | Active comparator | Patients wear Gastro-laryngeal tube after receiving general anesthesia for biliopancreatic procedures Receives: Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures. |
| LMA Gastro Airway Group (Group L) | Active comparator | Patients wear LMA Gastro Airway® after receiving general anesthesia for biliopancreatic procedures Receives: Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Oropharyngeal leak pressure is the airway pressure at which the circuit pressure stabilizes by closing the expiratory valve of the circle system at a constant gas flow of 3 L / min.
Measured: Intra-operative; after device insertion
Endoscopist satisfaction analysis: score
Endoscopist will score from 0 (worst) to 10 (best)
Measured: Immediately after the procedure
Leakage rate percentages
The leakage rate percentage is the calculation of the difference between the adjusted tidal volume and the exhaled tidal volume and then proportioning to the adjusted tidal volume.
Measured: Intra-operative; after device insertion at first minute
Secondary outcomes (3)
Hypopharyngeal/Esophageal Mucosal status
Number of patients with hyperemia, laceration (while extubating patient, endoscopist will take pictures of esophagus for if there is any mucosal damage). Esophageal and hypopharyngeal mucosal damage was determined in 5 grades by a visual mucosal damage scoring system [grade 1- normal mucosa, grade 2- mild hyperemia, grade 3-severe hyperemia, grade 4-bloody gross hyperemia, grade 5- laceration].
Measured: Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx
Blood staining on the device
Whether there is blood on the supraglottic airway device or not
Measured: Immediately after removing the supraglottic airway device
Presence of sore throat
Sore throat if present, was classified as mild, moderate or severe.
Measured: One hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start20 Nov 2019
- Primary completion20 Jun 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway EfficiencyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun UYSAL, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196582
- Sponsor's protocol ID
- Bezmialem Vakif University
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LMA® Gastro Airway and Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Observational Trial
- ClinicalTrials.gov ID
- NCT04196582
- Acronym / sponsor ID
- Bezmialem Vakif University
- Conditions
- Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration, Complication of Anesthesia, Esophagus Injury, Endoscopic Ergonomics
- Keywords
- LMA gastro airway, Gastro-laryngeal tube, ERCP, airway complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 20 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 12 Dec 2019 (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.
Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.
Detailed description
Supraglottic airway (SGA) devices are produced for avoiding endotracheal intubation for anesthesic interventions. Second generation SGA's like GLT and LMA® Gastro airway are using for endoscopic biliopancreatic procedures. Both of them have an airway canal and endoscopic canal. Although they can use for same reason, their designs are different. So, their airway securities, endoscopic manipulations and complications, would be different.
This study planned as single blind. American Society of Anesthesiologists (ASA) Physical status 1-2 100 patients which will be take endoscopic retrograde cholangiopancreatography (ERCP) included. The study starts after randomization and ends after discharge from the recovery room. All patients will be monitorised for hemodynamic parameters. Depth of anesthesia will be provided by bispectral index (BIS) monitoring. After anesthesia induction SGA will placed by an experienced anesthesiologist. Bilateral chest movements and auscultation, capnogram graphy and oropharyngeal leak pressure test will be used for confirmation of placement. After procedure endoscopist will take pictures of esophagus and hypopharynx. After extubation and sufficient consciousness and breathing of patient, patients will be transferred to post-anaesthesia care unit (PACU). Vital parameters will continue to monitoring in PACU. Patients will be discharge as usual with an Aldrete score ≥ 9.
Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastro-laryngeal tube Group (Group G) | Active comparator | Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.Patients wear Gastro-laryngeal tube after receiving general anesthesia for biliopancreatic procedures |
| LMA Gastro Airway Group (Group L) | Active comparator | Device: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.Patients wear LMA Gastro Airway® after receiving general anesthesia for biliopancreatic procedures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Physical Status 1-2
- Elective Procedures
- Weight 50-100 Kg
Key exclusion criteria (14 listed)
- Laryngeal mask airway contraindications.
- Anesthesic drug allergies
- Height <155 cm
- Body Mass index > 35 kg/m2
- Alcohol or narcotic drug usage
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 |
|---|---|---|
| Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures | Device | Gastro-laryngeal tube Group (Group G), LMA Gastro Airway Group (Group L) |
Primary outcome
Oropharyngeal leak pressure
Time frame: Intra-operative; after device insertion
Oropharyngeal leak pressure is the airway pressure at which the circuit pressure stabilizes by closing the expiratory valve of the circle system at a constant gas flow of 3 L / min.
Endoscopist satisfaction analysis: score
Time frame: Immediately after the procedure
Endoscopist will score from 0 (worst) to 10 (best)
Leakage rate percentages
Time frame: Intra-operative; after device insertion at first minute
The leakage rate percentage is the calculation of the difference between the adjusted tidal volume and the exhaled tidal volume and then proportioning to the adjusted tidal volume.
3 secondary outcomes
Hypopharyngeal/Esophageal Mucosal status
Time frame: Within the first minute after the procedure is completed, while the duodenoscope is being removed while it passes through the esophagus and hypopharynx
Blood staining on the device
Time frame: Immediately after removing the supraglottic airway device
Presence of sore throat
Time frame: One hour after extubation
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 3 Nov 2020.
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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 Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures. in people with Supraglottic Airway Efficiency and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 inclusion and 14 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 3 Nov 2020. 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 Turkey (Türkiye). 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?
Oropharyngeal leak pressure (time frame: Intra-operative; after device insertion). The study lists 3 primary outcomes in all. 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 3 Nov 2020.