Nasal Mask Kit in Gastrointestinal Endoscopy

RenJi Hospital1,204 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,204

Conditions

Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Cancer

Interventions

nasal mask oxygen kitDEVICE

Using the nasal mask oxygen kit for oxygenation.

regular nasal cannulaDEVICE

Using nasal cannula for oxygenation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (3)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Renji Hospital

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Outcomes

Primary Outcomes

The incidence of hypoxia

(75% ≤ SpO2 \< 90% for \<60 s)

Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Secondary Outcomes

The incidence of sub-clinical respiratory depression

(90% ≤ SpO2 \< 95%)

Time frame: 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)

Time frame: 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

Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]

Data from ClinicalTrials.gov

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