High Flow Nasal Cannula, Body Roundness Index
Conditions
Brief summary
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia. Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.
Interventions
PROCEDUREHigh Flow Nasal Cannula Oxygenation
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
PROCEDUREFace Mask Oxygenation
conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA class ≤Ⅲ * Visceral obesity（body mass index≥28 and BRI ≥5.46） * Patients who will undergo sedated gastroscopy
Exclusion criteria
* Life-threatening heart disease or acute myocardial infarction within 6 weeks * Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema * Upper respiratory tract infection * Presence of tracheostomy * Nasal or nasopharyngeal diseases * Coagulation disorders or a tendency of nose bleeding * Pregnancy * Recent (within 1 week) thoracic surgery * Emergent procedure or surgery * Allergy to drugs used during the procedure * Unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypoxia | From sedation with propofol to the end of the gastroscopy | SpO2\<90% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subclinical respiratory depression | From sedation with propofol to the end of the gastroscopy | 90%≤SpO2\<95% |
| Severe hypoxia | From sedation with propofol to the end of the gastroscopy | SpO2\<75% for any duration or 75%≤SpO2\<90% for \>60 s |
| Serious cardiac events | Through gastroscopy completion, an average of 10-15 minutes | Hypotension: Mean arterial pressure (MAP) \< 65 mmHg; hypertension: MAP \> 90 mmHg |
| Serious adverse respiratory events | Through gastroscopy completion, an average of 10-15 minutes | Apnea, tracheospasm, larynx spasm |
Countries
China
Contacts
Primary ContactWenling Zhao
Outcome results
None listed