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

Not Applicable

Completed

• Conditions: Hypoxia; Esophagus Cancer; Adverse Event; Gastric Cancer
• Interventions: Device: High-flow nasal cannula oxygenation

• Registration Number: NCT03332433
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-11-10
• Primary Completion: 2018-02-28
• Study Completion: 2018-03-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-02
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2034

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal cannula group	High-flow nasal cannula oxygenation	Oxygen(up to 60L/min) supplied with high-flow nasal cannula

Primary Outcome Measures

Name	Time	Method
Incidence of hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	(75% ≤ SpO2 \< 90% for \<60 s)

Secondary Outcome Measures

Name	Time	Method
Other adverse events	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	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.
Incidence of subclinical respiratory depression	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	(90% ≤ SpO2 \< 95%)
Incidence of severe hypoxia	Patients will be followed for the duration of hospital stay, an expected average of 2 hours	(SpO2 \< 75% for any duration or 75% ≤ SpO2 \< 90% for \>/=60 s)

Trial Locations

Locations (3)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China

Renji hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Pudong New Area People's Hospital; 🇨🇳 Shanghai, Shanghai, China