Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05783050
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 3.1

Study Details

Study Description

Brief 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 different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy

Condition or Disease	Intervention/Treatment	Phase
Supraglottic Airway Obstruction; Airway Complication of Anesthesia; Airway Obstruction; Anesthesia Complication; Bronchospasm; Nasal Bleeding; Oxygen Deficiency	Device: Wei Nasal Jet Tube; Device: Nasal Cannula Oxygen Support	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: computer-assisted randomization method
• Primary Purpose: Prevention
• Official Title: Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Jun 15, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Wei Nasal Jet Tube Group (Group W) After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.	Device: Wei Nasal Jet Tube; 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.
Active Comparator: Nasal Cannula Oxygen Support Group (Group N) After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.	Device: Nasal Cannula Oxygen Support; 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.

Outcome Measures

Primary Outcome Measures

1. Hypoxia incidence [Intra-operative; after device insertion]

   Hypoxia is defined as SpO2 <92% at any time.

Secondary Outcome Measures

1. Airway assist maneuver required [Intra-operative; after device insertion]

   When the SpO2 value is below 90-92%, airway support maneuvers will be performed

2. Procedure failure incidence [Intra-operative; after device insertion]

   The development of severe hypotension (MAP <55 mmHG), bradycardia ( HR< 45 bpm) and prolonged deep hypoxia(>60 sec SpO2<92%) during procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Principal Investigator: ISMAIL SUMER, MD, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: İsmail SÜMER, Principal Investigator, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT05783050
• Other Study ID Numbers: Ismail04
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by İsmail SÜMER, Principal Investigator, Bezmialem Vakif University: Wei Nasal Jet Tube; Airway Complication; Nasal Cannula Oxygen Support; Gastrointestinal Endoscopy; sedation
• Additional relevant MeSH terms: Airway Obstruction; Bronchial Spasm; Epistaxis; Hypoxia

Study Results

No Results Posted as of Mar 24, 2023