High Flow Nasal Oxygen Therapy Undergoing Colonoscopy

May 25, 2022 updated by: Turkish Society of Anesthesiology and Reanimation

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoxia
Time Frame: during the procedure
oxygen saturation <92
during the procedure
apnea
Time Frame: during the procedure
spontaneous breathing not longer than 10 seconds
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Society of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 26, 2022

Primary Completion (ANTICIPATED)

November 12, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (ACTUAL)

May 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gemlikanesthesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

researchers should explain the purpose of using individual participant data

IPD Sharing Time Frame

when the study data is fully collected

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Apnea

Clinical Trials on High Flow Nasal Cannula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe