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

Not Applicable

Completed

• Conditions: Nasal Bleeding; Airway Obstruction; Airway Complication of Anesthesia; Anesthesia Complication; Oxygen Deficiency; Supraglottic Airway Obstruction; Bronchospasm
• Interventions: Device: Wei Nasal Jet Tube; Device: Nasal Cannula Oxygen Support

• Registration Number: NCT05783050
• Lead Sponsor: Bezmialem Vakif University

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

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-03-30
• Primary Completion: 2023-06-15
• Study Completion: 2023-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wei Nasal Jet Tube Group (Group W)	Wei Nasal Jet Tube	After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients.
Nasal Cannula Oxygen Support Group (Group N)	Nasal Cannula Oxygen Support	After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients.

Primary Outcome Measures

Name	Time	Method
Hypoxia incidence	Intra-operative; after device insertion	Hypoxia is defined as SpO2 \<92% at any time.

Secondary Outcome Measures

Name	Time	Method
Airway assist maneuver required	Intra-operative; after device insertion	When the SpO2 value is below 90-92%, airway support maneuvers will be performed
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

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey