Supraglottic Airway ObstructionNCT05783050
Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients
A study testing Wei Nasal Jet Tube and Nasal Cannula Oxygen Support in people with Supraglottic Airway Obstruction and Airway Complication of Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction
- What is being tested?
- Wei Nasal Jet Tube and Nasal Cannula Oxygen Support
- 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
- 30 Mar 2023to 1 Jul 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing gastrointestinal endoscopy
- ASA Physical Status 1-2
- 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 and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study
Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy
Read the detailed description
Gastrointestinal endoscopy is performed as standard for the diagnosis of many gastrointestinal diseases. During gastrointestinal endoscopy, sedoanalgesia is applied to relieve patients' pain and increase patient comfort. Anesthetic drugs used for sedoanalgesia may cause respiratory depression and hypoxia in patients. Hypoxia resulting from hypoventilation in patients is responsible for many events, including coronary ischemia. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia. The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. Our study will show us which method is more beneficial in preventing hypoxia and other side effects, providing comfort for the doctor performing the procedure and for the patient undergoing the procedure. This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy
- Conditions
- Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction, Anesthesia Complication, Bronchospasm, Nasal Bleeding
- Being tested
- Wei Nasal Jet Tube, Nasal Cannula Oxygen Support
- Keywords
- Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation
- Medical subject headings
- Airway Obstruction, Bronchial Spasm, Epistaxis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wei Nasal Jet TubeDevice
The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.
Nasal Cannula Oxygen SupportDevice
The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices.
| 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 |
| Nasal Cannula Oxygen Support Group (Group N) | Active comparator | After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients. Receives: Device: Nasal Cannula Oxygen Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia incidence
Hypoxia is defined as SpO2 <92% at any time.
Measured: Intra-operative; after device insertion
Secondary outcomes (2)
Airway assist maneuver required
When the SpO2 value is below 90-92%, airway support maneuvers will be performed
Measured: Intra-operative; after device insertion
Procedure failure incidence
The development of severe hypotension (MAP <55 mmHG), bradycardia ( HR< 45 bpm) and prolonged deep hypoxia(>60 sec SpO2<92%) during 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 posted24 Mar 2023
- Study start30 Mar 2023
- Primary completion15 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway ObstructionStudies 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
- Prevention
- 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, İsmail SÜMER, Bezmialem Vakif University
- Investigators
- ISMAIL SUMER, MD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783050
- Sponsor's protocol ID
- Ismail04
- Status last verified
- Aug 2024
- First submitted
- 13 Mar 2023
- Last updated
- 12 Aug 2024
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05783050
- Acronym / sponsor ID
- Ismail04
- Conditions
- Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction, Anesthesia Complication, Bronchospasm, Nasal Bleeding
- Keywords
- Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Mar 2023 (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.
Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy
Detailed description
Gastrointestinal endoscopy is performed as standard for the diagnosis of many gastrointestinal diseases. During gastrointestinal endoscopy, sedoanalgesia is applied to relieve patients' pain and increase patient comfort. Anesthetic drugs used for sedoanalgesia may cause respiratory depression and hypoxia in patients. Hypoxia resulting from hypoventilation in patients is responsible for many events, including coronary ischemia. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia. The purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. Our study will show us which method is more beneficial in preventing hypoxia and other side effects, providing comfort for the doctor performing the procedure and for the patient undergoing the procedure. This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy
Study design
- Primary purpose
- Prevention
- 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. |
| Nasal Cannula Oxygen Support Group (Group N) | Active comparator | Device: Nasal Cannula Oxygen SupportAfter the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing gastrointestinal endoscopy
- ASA Physical Status 1-2
- Body mass index 18.5 - 35 kg/m2
Key exclusion criteria (12 listed)
- High risk of pulmonary aspiration
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 TubeThe purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. | Device | Wei Nasal Jet Tube Group (Group W) |
| Nasal Cannula Oxygen SupportThe purpose of this procedure is to provide safe oxygenation and ventilation. While providing oxygen support, nasal cannula, classical oxygen mask can be used, as well as new generation oxygenation devices. | Device | Nasal Cannula Oxygen Support Group (Group N) |
Primary outcome
Hypoxia incidence
Time frame: Intra-operative; after device insertion
Hypoxia is defined as SpO2 <92% at any time.
2 secondary outcomes
Airway assist maneuver required
Time frame: Intra-operative; after device insertion
Procedure failure incidence
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 12 Aug 2024.
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.
ISMAIL SUMER, MD 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 Nasal Cannula Oxygen Support in people with Supraglottic Airway Obstruction 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 12 Aug 2024. 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 incidence (time frame: Intra-operative; after device insertion). 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 12 Aug 2024.