Airway Obstruction Clinical Trial
Official title:
Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study
NCT number | NCT05783050 |
Other study ID # | Ismail04 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 30, 2023 |
Est. completion date | July 1, 2023 |
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
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2023 |
Est. primary completion date | June 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients undergoing gastrointestinal endoscopy - ASA Physical Status 1-2 - Body mass index 18.5 - 35 kg/m2 Exclusion Criteria: - High risk of pulmonary aspiration - Pregnancy - Anesthesic drug allergies - Difficult airway or facial deformities - Height <155 cm - Alcohol or narcotic drug usage - 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoxia incidence | Hypoxia is defined as SpO2 <92% at any time. | Intra-operative; after device insertion | |
Secondary | Airway assist maneuver required | When the SpO2 value is below 90-92%, airway support maneuvers will be performed | Intra-operative; after device insertion | |
Secondary | 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 | Intra-operative; after device insertion |
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