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High Flow Nasal Oxygen Therapy Undergoing Colonoscopy

Sponsor
Turkish Society of Anesthesiology and Reanimation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05396274
Collaborator
(none)
70
Enrollment
2
Arms
7.2
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: High Flow Nasal Cannula
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Investigation of the Clinical Efficacy of High Flow Nasal Oxygen in Patients Over 60 Years of Age Undergoing Colonoscopy
Anticipated Study Start Date :
May 26, 2022
Anticipated Primary Completion Date :
Nov 12, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: standard nasal therapy

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

Device: High Flow Nasal Cannula
high flow nasale cannula
Active Comparator: high flow nasal cannula

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

Device: High Flow Nasal Cannula
high flow nasale cannula

Outcome Measures

Primary Outcome Measures

  1. hypoxia [during the procedure]

    oxygen saturation <92

  2. apnea [during the procedure]

    spontaneous breathing not longer than 10 seconds

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Turkish Society of Anesthesiology and Reanimation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Turkish Society of Anesthesiology and Reanimation
ClinicalTrials.gov Identifier:
NCT05396274
Other Study ID Numbers:
  • gemlikanesthesia
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Turkish Society of Anesthesiology and Reanimation
High Flow Nasal Oxygen
nasal cannula
colonoscopy
Additional relevant MeSH terms:
Hypoxia

Study Results

No Results Posted as of May 31, 2022