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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783050
• Other study ID #: Ismail04
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2023
• Source: Bezmialem Vakif University
• Contact: ISMAIL SUMER, MD
• Phone: 00905332201576
• Email: drismailsumer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Airway Obstruction
• Anesthesia Complication
• Bronchial Spasm
• Bronchospasm
• Epistaxis
• Hypoxia
• Nasal Bleeding
• Oxygen Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

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