Nasal Mask Kit in Gastrointestinal Endoscopy

Gastric Cancer Clinical Trial

— NASO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05405530
• Other study ID #: RenJiH-2022-01-04
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: RenJi Hospital
• Contact: Diansan Su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colon Polyp
• Esophageal Cancer
• Gastric Cancer
• Gastric Polyp
• Hypoxia
• Polyps

Intervention

Device:
• nasal mask oxygen kit
Using the nasal mask oxygen kit for oxygenation.
• regular nasal cannula
Using nasal cannula for oxygenation.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Renji Hospital	Shanghai	Shanghai
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Henan Provincial People's Hospital, The First Affiliated Hospital of Kunming Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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
Secondary	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]