Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University
About this trial
High flow nasal cannula oxygenation (HFNC) offers high flow and concentration oxygen delivery, providing excellent non-respiratory oxygenation. As a relatively new oxygen delivery method, it has gained widespread use. We have demonstrated that high flow nasal cannula oxygenation reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with American Anesthesiologist Rating (ASA rating) grades 1 to 2 and obesity. We hypothesized that HFNC could mitigate the risk of hypoxia in critical patients during sedated gastrointestinal endoscopy. To confirm this, we selected critical patients with ASA grades 3 to 4 who were scheduled for gastrointestinal endoscopy. We observed and compared the incidence of hypoxia (75%≤SpO2 \< 90% and \< 60S), severe hypoxia (SpO2\<75% for any duration or 75%≤SpO2 \< 90%, ≥60s), subclinical respiratory depression (90%≤SpO2 \< 95%), respiratory-related adverse events, sedation-related adverse events, and complications associated with high flow nasal cannula oxygenation using HFNC or regular nasal cannula during the sedated gastrointestinal endoscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18≤ age ≤80, gender is not limited;
Patients undergoing elective gastroenteroscopy or treatment;
ASA grade Ⅲ~Ⅳ;
18 kg/m2≤BMI≤28kg/m2;
Disqualifiers
Patients with nasal congestion, nasal bleeding, recent nasal trauma, recent nasal surgery, increased intracranial pressure and skull fracture, etc., who can not perform high-flow nasal catheter oxygen;
acute respiratory infections and asthma attacks;
Patients diagnosed with COPD;
Clear difficult airway;
Trial design
Design model
Parallel
Treatments tested in this trial
High-flow nasal catheter oxygen
DeviceBefore induction of anesthesia, connect the Airvo2 (HFNC high flow device) special nasal cannula to inhale oxygen, and preoxygenate with an oxygen flow rate of 6L /min. After induction of anesthesia, adjust the oxygen flow rate to 60L /min, oxygen concentration 100%, oxygen temperature 37℃ until the end of gastrointestinal endoscopy.
regular nasal catheter oxygen
DeviceBefore anesthesia induction, a disposable nasal catheter oxygen inhalation device (covered by HFNC nasal catheter and blinded to the patient) was connected to an oxygen source for pre-oxygen inhalation, 6L/min. After induction of anesthesia, oxygen was continued for 6L/min until the end of gastroenteroscopy.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: High-flow nasal catheter oxygenExperimental treatment 1 intervention
Group B: Regular nasal catheter oxygenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of hypoxia
75%≤ SpO2 \< 90% and \< 60S
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSecondary outcomes
1
Incidence of severe hypoxia
SpO2\<75% for any duration, or 75%≤SpO2 \< 90%, ≥60s
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours2
Incidence of subclinical respiratory depression
90%≤ SpO2\<95%
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursOther outcomes
1
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSponsors and contacts
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Source ClinicalTrials.gov