Back to resultsNasal Mask Kit in Gastrointestinal Endoscopy (NASO)
Primary Purpose
Hypoxia, Gastric Cancer, Gastric Polyp
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nasal mask oxygen kit
regular nasal cannula
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia focused on measuring nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring
Eligibility Criteria
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
Sites / Locations
- Henan Provincial People's Hospital
- Renji HospitalRecruiting
- First Affiliated Hospital of Kunming Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nasal mask oxygen group
regular nasal cannula group
Arm Description
In this group, patients use the nasal mask oxygen kit for oxygenation.
In this group, patients use the regular nasal cannula for oxygenation.
Outcomes
Primary Outcome Measures
The incidence of hypoxia
(75% ≤ SpO2 < 90% for <60 s)
Secondary Outcome Measures
The incidence of sub-clinical respiratory depression
(90% ≤ SpO2 < 95%)
The incidence of severe hypoxia
(SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s)
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Full Information
NCT ID
NCT05405530
First Posted
June 1, 2022
Last Updated
September 6, 2022
Sponsor
RenJi Hospital
Collaborators
Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05405530
Brief Title
Nasal Mask Kit in Gastrointestinal Endoscopy
Acronym
NASO
Official Title
Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
Henan Provincial People's Hospital, First Affiliated Hospital of Kunming Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer
Keywords
nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nasal mask oxygen group
Arm Type
Experimental
Arm Description
In this group, patients use the nasal mask oxygen kit for oxygenation.
Arm Title
regular nasal cannula group
Arm Type
Active Comparator
Arm Description
In this group, patients use the regular nasal cannula for oxygenation.
Intervention Type
Device
Intervention Name(s)
nasal mask oxygen kit
Intervention Description
Using the nasal mask oxygen kit for oxygenation.
Intervention Type
Device
Intervention Name(s)
regular nasal cannula
Intervention Description
Using nasal cannula for oxygenation.
Primary Outcome Measure Information:
Title
The incidence of hypoxia
Description
(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 Outcome Measure Information:
Title
The incidence of sub-clinical respiratory depression
Description
(90% ≤ SpO2 < 95%)
Time Frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Title
The incidence of severe hypoxia
Description
(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
Title
The incidence of other adverse events
Description
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]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyang Cheng, B.S.
Phone
+862168383702
Email
1647384344@qq.com
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqiang zhang, Dr
Phone
+8613937121360
Email
hnmzxh@163.com
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiangyang cheng, B.S
Phone
+862168383702
Email
1647384344@qq.com
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianlin shao, Dr
Phone
+8613888586162
Email
cmushaojl@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Nasal Mask Kit in Gastrointestinal Endoscopy
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