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

Primary Purpose

Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wei Nasal Jet Tube
Nasal Cannula Oxygen Support
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Supraglottic Airway Obstruction focused on measuring Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Wei Nasal Jet Tube Group (Group W)

Nasal Cannula Oxygen Support Group (Group N)

Arm Description

After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.

After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2023
Last Updated
April 11, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT05783050
Brief Title
Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients
Official Title
Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction, Anesthesia Complication, Bronchospasm, Nasal Bleeding, Oxygen Deficiency
Keywords
Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
computer-assisted randomization method
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wei Nasal Jet Tube Group (Group W)
Arm Type
Active Comparator
Arm Description
After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Arm Title
Nasal Cannula Oxygen Support Group (Group N)
Arm Type
Active Comparator
Arm Description
After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.
Intervention Type
Device
Intervention Name(s)
Wei Nasal Jet Tube
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nasal Cannula Oxygen Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hypoxia incidence
Description
Hypoxia is defined as SpO2 <92% at any time.
Time Frame
Intra-operative; after device insertion
Secondary Outcome Measure Information:
Title
Airway assist maneuver required
Description
When the SpO2 value is below 90-92%, airway support maneuvers will be performed
Time Frame
Intra-operative; after device insertion
Title
Procedure failure incidence
Description
The development of severe hypotension (MAP <55 mmHG), bradycardia ( HR< 45 bpm) and prolonged deep hypoxia(>60 sec SpO2<92%) during procedure
Time Frame
Intra-operative; after device insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ISMAIL SUMER, MD
Phone
00905332201576
Email
drismailsumer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ISMAIL SUMER, MD
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
İsmail Sumer, MD
Phone
0095332201576
Email
isumer@bezmailem.edu.tr

12. IPD Sharing Statement

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

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