NCT05396274

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 22, 2022

Last Update Submit

May 25, 2022

Conditions

Keywords

High Flow Nasal Oxygennasal cannulacolonoscopy

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 COMPARATOR

nasal oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation

Device: High Flow Nasal Cannula

high flow nasal cannula

ACTIVE COMPARATOR

High Flow Nasal Oxygen was applied for procedure %40 inspired oxygen fraction five minutes preoxygenation

Device: High Flow Nasal Cannula

Interventions

high flow nasale cannula

high flow nasal cannulastandard nasal therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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: 30391445BACKGROUND
  • 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.

    PMID: 32925331BACKGROUND

MeSH Terms

Conditions

ApneaHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

FERİT YETİK, 2

CONTACT

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

researchers should explain the purpose of using individual participant data

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
when the study data is fully collected