Clinical trial NCT03332433: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol
Official title: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol: a Randomized Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Gastric Cancer
Esophagus Cancer
Adverse Event
Keywords: Hypoxia
Gastroscope
High-flow nasal cannula
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong New Area People's Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2017-11-06
Enrollment: 2034
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Incidence of subclinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: Other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
Study officials:
References:
citation: Lin Y, Zhang X, Li L, Wei M, Zhao B, Wang X, Pan Z, Tian J, Yu W, Su D. High-flow nasal cannula oxygen therapy and hypoxia during gastroscopy with propofol sedation: a randomized multicenter clinical trial. Gastrointest Endosc. 2019 Oct;90(4):591-601. doi: 10.1016/j.gie.2019.06.033. Epub 2019 Jul 3.