High Flow Nasal Oxygen Therapy Undergoing Colonoscopy

NCT ID: NCT05396274

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Apnea Hypoxia

Keywords

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High Flow Nasal Oxygen nasal cannula colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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standard nasal therapy

nasal oxygen was applied for procedure

%40 inspired oxygen fraction five minutes preoxygenation

Group Type ACTIVE_COMPARATOR

High Flow Nasal Cannula

Intervention Type DEVICE

high flow nasale cannula

high flow nasal cannula

High Flow Nasal Oxygen was applied for procedure

%40 inspired oxygen fraction five minutes preoxygenation

Group Type ACTIVE_COMPARATOR

High Flow Nasal Cannula

Intervention Type DEVICE

high flow nasale cannula

Interventions

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High Flow Nasal Cannula

high flow nasale cannula

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Anesthesiology and Reanimation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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UTKU SAĞLAM, 1

Role: CONTACT

Phone: 905079701310

Email: [email protected]

FERİT YETİK, 2

Role: CONTACT

Phone: 905068104523

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 30391445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32925331 (View on PubMed)

Other Identifiers

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gemlikanesthesia

Identifier Type: -

Identifier Source: org_study_id