High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

Gastric Cancer Clinical Trial

— HONCHO  

Official title:

High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332433
• Other study ID #: RenJiH-20170724
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: September 2018
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2034
• Est. completion date: March 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing gastroscope

• age over 18 years old

• Signed informed consent form

Exclusion Criteria:

• Coagulation disorders or a tendency of nose bleeding;

• An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;

• Severe aortic stenosis or mitral stenosis;

• Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;

• Acute myocardial infarction in the last 6 months;

• Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability;

• Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);

• Increased intracranial pressure;

• ASA >III;

• Mouth, nose, or throat infection;

• Fever, defined as core body temperature > 37.5oC ;

• Pregnancy, breastfeeding or positive pregnancy test

• Emergency procedure

Related Conditions & MeSH terms

• Adverse Event
• Esophageal Neoplasms
• Esophagus Cancer
• Gastric Cancer
• Hypoxia
• Stomach Neoplasms

Intervention

Device:
• High-flow nasal cannula oxygenation
Oxygen is supplied with a high-flow nasal cannula oxygenation device,the flow is up to 60L/min

Locations

Country	Name	City	State
China	Renji hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai Pudong New Area People's Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoxia	(75% = SpO2 < 90% for <60 s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	Incidence of subclinical respiratory depression	(90% = SpO2 < 95%)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	Incidence of severe hypoxia	(SpO2 < 75% for any duration or 75% = SpO2 < 90% for >/=60 s)	Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary	Other adverse events	Other adverse events include other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours