Adverse Event, Esophagus Cancer, Gastric Cancer, Hypoxia
Conditions
Keywords
Hypoxia, Gastroscope, High-flow nasal cannula
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.
Interventions
Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min
Sponsors
Shanghai Pudong New Area People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Countries
China
Outcome results
None listed