High Flow Nasal Oxygen Therapy Undergoing Colonoscopy
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2022
CompletedStudy Start
First participant enrolled
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 31, 2022
May 1, 2022
6 months
May 22, 2022
May 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
hypoxia
oxygen saturation \<92
during the procedure
apnea
spontaneous breathing not longer than 10 seconds
during the procedure
Study Arms (2)
standard nasal therapy
ACTIVE COMPARATORnasal oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation
high flow nasal cannula
ACTIVE COMPARATORHigh Flow Nasal Oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 30391445BACKGROUNDSpence 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.
PMID: 32925331BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2022
First Posted
May 31, 2022
Study Start
May 26, 2022
Primary Completion
November 12, 2022
Study Completion
December 30, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- when the study data is fully collected
researchers should explain the purpose of using individual participant data