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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
Turkish Society of Anesthesiology and Reanimation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea focused on measuring High Flow Nasal Oxygen, nasal cannula, colonoscopy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 22, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Turkish Society of Anesthesiology and Reanimation
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    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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