High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
Primary Purpose
Apnea, Hypoxia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Sponsored by
About this trial
This is an interventional prevention trial for Apnea focused on measuring High Flow Nasal Oxygen, nasal cannula, colonoscopy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard nasal therapy
high flow nasal cannula
Arm Description
nasal oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation
High Flow Nasal Oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation
Outcomes
Primary Outcome Measures
hypoxia
oxygen saturation <92
apnea
spontaneous breathing not longer than 10 seconds
Secondary Outcome Measures
Full Information
NCT ID
NCT05396274
First Posted
May 22, 2022
Last Updated
May 25, 2022
Sponsor
Turkish Society of Anesthesiology and Reanimation
1. Study Identification
Unique Protocol Identification Number
NCT05396274
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 26, 2022 (Anticipated)
Primary Completion Date
November 12, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turkish Society of Anesthesiology and Reanimation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Hypoxia
Keywords
High Flow Nasal Oxygen, nasal cannula, colonoscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard nasal therapy
Arm Type
Active Comparator
Arm Description
nasal oxygen was applied for procedure
%40 inspired oxygen fraction five minutes preoxygenation
Arm Title
high flow nasal cannula
Arm Type
Active Comparator
Arm Description
High Flow Nasal Oxygen was applied for procedure
%40 inspired oxygen fraction five minutes preoxygenation
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
high flow nasale cannula
Primary Outcome Measure Information:
Title
hypoxia
Description
oxygen saturation <92
Time Frame
during the procedure
Title
apnea
Description
spontaneous breathing not longer than 10 seconds
Time Frame
during the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UTKU SAĞLAM, 1
Phone
905079701310
Email
utkusaglam23@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FERİT YETİK, 2
Phone
905068104523
Email
frtytk@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
researchers should explain the purpose of using individual participant data
IPD Sharing Time Frame
when the study data is fully collected
Citations:
PubMed Identifier
30391445
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.
Results Reference
background
PubMed Identifier
32925331
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.
Results Reference
background
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High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
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