High Flow Nasal Oxygen Therapy Undergoing Colonoscopy

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05396274
• Other study ID #: gemlikanesthesia
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: Turkish Society of Anesthesiology and Reanimation
• Contact: UTKU SAGLAM, 1
• Phone: 905079701310
• Email: utkusaglam23[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 30, 2022
• Est. primary completion date: November 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Hypoxia

Intervention

Device:
• High Flow Nasal Cannula
high flow nasale cannula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Society of Anesthesiology and Reanimation

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoxia	oxygen saturation <92	during the procedure
Primary	apnea	spontaneous breathing not longer than 10 seconds	during the procedure