Supraglottic Airway EfficiencyNCT05360810
Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
A study testing Wei Nasal Jet Tube and Gastro Laryngeal Tube in people with Supraglottic Airway Efficiency and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures. 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?
- Wei Nasal Jet Tube and Gastro Laryngeal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to 15 Aug 2022
- 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
- Body mass index 18.5 - 35 kg/m2
Who cannot join
- High risk of pulmonary aspiration
- Pregnancy
- Anesthesic drug allergies
- Difficult airway or facial deformities
- Height <155 cm
- Alcohol or narcotic drug usage
Show all 12Show fewer
- Restrictive or obstructive pulmonary diseases
- Hepatic cardiac or renal failure
- Neurologic or cognitive deficiencies.
- Previous cervical surgery or cervical radiotherapy
- Previous esophagus surgery
- Psychotic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.
Read the detailed description
ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition.
In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.
- Conditions
- Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration, Complication of Anesthesia, Esophagus Injury, Endoscopic Ergonomics
- Being tested
- Wei Nasal Jet Tube, Gastro Laryngeal Tube
- Keywords
- Wei Nasal Jet Tube, Gastro-laryngeal tube, ERCP, Airway Complication, Hipoxia
- Medical subject headings
- Epistaxis, Bronchial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wei Nasal Jet TubeDevice
Also called Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
airway devices which can use for gastrointestinal procedures
Gastro Laryngeal TubeDevice
Also called Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.
comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
| Study group | Role | What they receive |
|---|---|---|
| Wei Nasal Jet Tube Group (Group W) | Active comparator | After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients. Receives: Device: Wei Nasal Jet Tube |
| Gastro-Laryngeal Tube Group (Group G) | Active comparator | After the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients. Receives: Device: Gastro Laryngeal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia İncidence
Hypoxia is defined as SpO2 <92% at any time.
Measured: Intra-operative; after device insertion
Endoscopist Satisfaction Analysis: Score
It is determined by the endoscopist according to the endoscopy satisfaction scale according to the maneuverability of the duodenoscope and the number of insertion attempts. (0-10 Points) The endocopist satisfaction score is scored on a minimum score of 0 and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction.
Measured: Intra-operative, during the procedure
Secondary outcomes (3)
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
Incidence of hypercapnia
Hypercapnia is EtCO2 >45 mmHg at any time during the procedure
Measured: Intra-operative; after device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start10 May 2022
- Primary completion1 Aug 2022
- Study completion15 Aug 2022
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 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
- Investigators
- Harun Uysal, M.D., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360810
- Sponsor's protocol ID
- BezmialemVakifU
- Status last verified
- Sep 2022
- First submitted
- 29 Apr 2022
- Last updated
- 15 Sep 2022
- 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 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Observational Study
- ClinicalTrials.gov ID
- NCT05360810
- Acronym / sponsor ID
- BezmialemVakifU
- Conditions
- Supraglottic Airway Efficiency, Airway Complication of Anesthesia, Airway Aspiration, Complication of Anesthesia, Esophagus Injury, Endoscopic Ergonomics
- Keywords
- Wei Nasal Jet Tube, Gastro-laryngeal tube, ERCP, Airway Complication, Hipoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 4 May 2022 (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.
The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.
Detailed description
ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition.
In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wei Nasal Jet Tube Group (Group W) | Active comparator | Device: Wei Nasal Jet TubeAfter induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients. |
| Gastro-Laryngeal Tube Group (Group G) | Active comparator | Device: Gastro Laryngeal TubeAfter the induction of anesthesia, the Gastro Laryngeal Tube was placed in the patients. |
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
- Body mass index 18.5 - 35 kg/m2
Key exclusion criteria (12 listed)
- High risk of pulmonary aspiration
- Pregnancy
- Anesthesic drug allergies
- Difficult airway or facial deformities
- Height <155 cm
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 |
|---|---|---|
| Wei Nasal Jet TubeAlso: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures airway devices which can use for gastrointestinal procedures | Device | Wei Nasal Jet Tube Group (Group W) |
| Gastro Laryngeal TubeAlso: Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will ERCP procedures.comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures | Device | Gastro-Laryngeal Tube Group (Group G) |
Primary outcome
Hypoxia İncidence
Time frame: Intra-operative; after device insertion
Hypoxia is defined as SpO2 <92% at any time.
Endoscopist Satisfaction Analysis: Score
Time frame: Intra-operative, during the procedure
It is determined by the endoscopist according to the endoscopy satisfaction scale according to the maneuverability of the duodenoscope and the number of insertion attempts. (0-10 Points) The endocopist satisfaction score is scored on a minimum score of 0 and a maximum of 10 points. A score of 0 means I am not satisfied at all, a score of 10 means very satisfied. A higher score indicates higher satisfaction.
3 secondary outcomes
Blood staining on the device
Time frame: Immediately after removing the supraglottic airway device
Presence of sore throat
Time frame: One hour after extubation
Incidence of hypercapnia
Time frame: Intra-operative; after device insertion
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 15 Sep 2022.
Related trials for Supraglottic Airway Efficiency
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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.
Harun Uysal, M.D. principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wei Nasal Jet Tube and Gastro Laryngeal Tube 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 12 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 15 Sep 2022. 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?
Hypoxia İncidence (time frame: Intra-operative; after device insertion). The study lists 2 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 15 Sep 2022.