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

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Wei Nasal Jet Tube and Nasal Cannula Oxygen Support Methods in Sedated Gastrointestinal Endoscopy Patients: A Prospective, Randomized Controlled Study

Conditions
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Supraglottic Airway Obstruction, Airway Complication of Anesthesia, Airway Obstruction, Anesthesia Complication, Bronchospasm, Nasal Bleeding, Oxygen Deficiency

Intervention / Treatment
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* Device: Wei Nasal Jet Tube
* Device: Nasal Cannula Oxygen Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wei Nasal Jet Tube Group (Group W)<br>After induction of anesthesia, the Wei Nasal Jet Tube was placed in the patients. | Device: Wei Nasal Jet Tube<br>* 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.<br>|
| Active Comparator: Nasal Cannula Oxygen Support Group (Group N)<br>After the induction of anesthesia, the Nasal Cannula Oxygen Cannula was placed in the patients. | Device: Nasal Cannula Oxygen Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia incidence | Hypoxia is defined as SpO2 <92% at any time. | Intra-operative; after device insertion | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wei Nasal Jet Tube, Airway Complication, Nasal Cannula Oxygen Support, Gastrointestinal Endoscopy, sedation