Nasal Mask Kit in Gastrointestinal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-06

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.

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Detailed Description

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Conditions

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Hypoxia Gastric Cancer Gastric Polyp Colon Polyp Colon Cancer Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nasal mask oxygen group

In this group, patients use the nasal mask oxygen kit for oxygenation.

Group Type EXPERIMENTAL

nasal mask oxygen kit

Intervention Type DEVICE

Using the nasal mask oxygen kit for oxygenation.

regular nasal cannula group

In this group, patients use the regular nasal cannula for oxygenation.

Group Type ACTIVE_COMPARATOR

regular nasal cannula

Intervention Type DEVICE

Using nasal cannula for oxygenation.

Interventions

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nasal mask oxygen kit

Using the nasal mask oxygen kit for oxygenation.

Intervention Type DEVICE

regular nasal cannula

Using nasal cannula for oxygenation.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No