Clinical trial NCT04500392: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
Official title: High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity: a Randomized Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia
Gastric Cancer
Esophagus Cancer
Polyp of Colon
Colon Cancer
Keywords: Hypoxia
Gastrointestinal endoscopes
High-flow nasal cannula Oxygenation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Shanghai Oriental Hospital, Tongji University School of Medicine
First posted: 2020-08-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 event during gastrointestinal endoscopes sedated with propofol and sufentanil, especially in obese people. In the present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the incidence of hypoxia among obesity.


Eligibility criteria: Inclusion Criteria:

* patients undergoing gastrointestinal endoscopes
* age≥18 years old and ≤70 years old
* patients or family members signed informed consent form
* ASA classification I-II
* BMI≥ 28kg/m²

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 the fluid of hemodynamics 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 classification Ⅲ-Ⅳ ;
* Mouth, nose, or throat infection;
* Liver and kidney disease
* Fever, defined as core body temperature \> 37.5℃;
* Pregnancy, breastfeeding or positive pregnancy test;
* Emergency procedure;
* Patients or family members refused to participate
* Mental disorders and people without civil capacity

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours]
Secondary outcomes:
measure: The incidence of subclinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
measure: The 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 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.
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, China
city: Shanghai
country: China
facility: Shanghai Oriental Hospital
state: Shanghai, China
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai, China
Study officials:
affiliation: Renji Hospital, Shanghai Jiaotong University, Shanghai, China
name: Diansan Su, Dr.
role: PRINCIPAL_INVESTIGATOR
References: