Colon Cancer, Colon Polyp, Esophageal Cancer, Gastric Cancer, Gastric Polyp, Hypoxia
Conditions
Keywords
nasal mask, Hypoxia, Gastrointestinal endoscopy, Propofol, Capnographic Monitoring
Brief summary
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.
Interventions
DEVICEnasal mask oxygen kit
Using the nasal mask oxygen kit for oxygenation.
DEVICEregular nasal cannula
Using nasal cannula for oxygenation.
Sponsors
Henan Provincial People's Hospital
First Affiliated Hospital of Kunming Medical University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 18≤ Age ≤60 * patients undergoing combined gastroendoscopy and colonoscopy procedure * patients signed informed consent form * ASA classification I-II * Estimated procedure time \<=45min
Exclusion criteria
* Coagulation disorders or a tendency of nose bleeding * Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.) * Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy) * hypoxia (SpO2\< 90 % ) * Upper respiratory tract infection * increased intracranial pressure * Fever (core body temperature \>37.5 ℃) * Pregnancy, breastfeeding, or positive pregnancy test * Emergency procedure or surgery * Multiple trauma * Allergy to propofol or tape and adhesives * BMI\<18.5 or BMI\>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | (75% ≤ SpO2 \< 90% for \<60 s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of other adverse events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours] | (90% ≤ SpO2 \< 95%) |
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | (SpO2 \< 75% or 75% ≤ SpO2 \< 90% for \>/=60 s) |
Countries
China
Outcome results
None listed