Clinical trial NCT05396274: High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
Official title: Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apnea
Hypoxia
Keywords: High Flow Nasal Oxygen
nasal cannula
colonoscopy
Lead sponsor: Turkish Society of Anesthesiology and Reanimation
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy

Detailed description: 70 patients who underwent colonoscopy under elective conditions will be included in the study. Routine monitoring will be applied to the patients in the outpatient room in accordance with the standard protocol and the findings in the preoperative period will be recorded. The dose and frequency of anesthesia applied in the routine will not be interfered with and the recorded data will be collected by an observer other than the practitioner. Randomization between groups will be achieved by taking the patients on the surgical procedure list sequentially.

For both groups, after positioning the patients and placing the cannulas, preoxygenation will be performed for 5 minutes before induction of anesthesia. Oxygenation will be carried out at 35°C and 50 lt/min flow rate from the High Flow Nasal Cannula device, with inspired oxygen fraction equivalent to 40% in both groups, 5 lt/min in Group N, and inspired oxygen fraction equivalent to 40% in Group H, and immediately Anesthesia induction will then be applied.Oxygen saturation and other hemodynamic data of the patients in the room air before preoxygenation,oxygen saturation and hemodynamic data before induction after preoxygenation, oxygen saturation and hemodynamic data every minute during the procedure,oxygen saturation and hemodynamic data at the end of the procedure will be recorded. Interventions for respiratory safety, such as chin thrust, painful stimulus, inspired oxygen fraction increase, airway placement and mask ventilation, in case of apnea (stopping breathing for 10 seconds or more) or oxygen saturation ≤92% that may occur after induction until the end of the procedure , drug applications and other undesirable events will be recorded.

As a result of the study, High Flow Nasal Cannula and low flow nasal cannula, which is the standard conventional method, will be compared in terms of desaturation and hypoxemia in my colonoscopy procedures performed under sedation.

Eligibility criteria: Inclusion Criteria:

* Colonoscopy under elective conditions
* Patients aged 60 and over
* Having an American Society of Anesthesiology score of 1, 2, 3
* Approved and signed the informed consent form

Exclusion Criteria:

* Patients younger than 60 years
* Patients with an American Society of Anesthesiology score of 4 and above
* Emergency cases
* Patients who did not accept informed consent
* History of drug allergy and opioid tolerance
* Coagulation disorder
* Those who refused to participate in the study

Primary outcomes:
measure: hypoxia
timeFrame: during the procedure
measure: apnea
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Riccio CA, Sarmiento S, Minhajuddin A, Nasir D, Fox AA. High-flow versus standard nasal cannula in morbidly obese patients during colonoscopy: A prospective, randomized clinical trial. J Clin Anesth. 2019 May;54:19-24. doi: 10.1016/j.jclinane.2018.10.026. Epub 2018 Nov 2.
citation: Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073.