Nasal Mask Kit in Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.

Official Title
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Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial

Conditions
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Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer

Intervention / Treatment
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* Device: nasal mask oxygen kit
* Device: regular nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18≤ Age ≤60 patients undergoing combined gastroendoscopy and colonoscopy procedure patients signed informed consent form ASA classification I-II Estimated procedure time <=45min Exclusion Criteria: Coagulation disorders or a tendency of nose bleeding Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy) hypoxia (SpO2< 90 % ) Upper respiratory tract infection increased intracranial pressure Fever (core body temperature >37.5 ℃) Pregnancy, breastfeeding, or positive pregnancy test Emergency procedure or surgery Multiple trauma Allergy to propofol or tape and adhesives BMI<18.5 or BMI>30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nasal mask oxygen group<br>In this group, patients use the nasal mask oxygen kit for oxygenation. | Device: nasal mask oxygen kit<br>* Using the nasal mask oxygen kit for oxygenation.<br>|
| Active Comparator: regular nasal cannula group<br>In this group, patients use the regular nasal cannula for oxygenation. | Device: regular nasal cannula<br>* Using nasal cannula for oxygenation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hypoxia | (75% ≤ SpO2 < 90% for <60 s) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of sub-clinical respiratory depression | (90% ≤ SpO2 < 95%) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | 
| The incidence of severe hypoxia | (SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s) | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 
| The incidence of other adverse events | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring