Clinical trial NCT05783050: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Hypoxia incidence
timeFrame: Intra-operative; after device insertion
Secondary outcomes:
measure: Airway assist maneuver required
timeFrame: Intra-operative; after device insertion
measure: Procedure failure incidence
timeFrame: Intra-operative; after device insertion
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: ISMAIL SUMER, MD
role: PRINCIPAL_INVESTIGATOR
References: