The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time

July 2, 2019 updated by: ilkay baran akkuş, Ankara Diskapi Training and Research Hospital

Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery

The aim of the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Criteria for inclusion in the study:

Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years 50 patients

  1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during preoxygenation will be included.
  2. Group: Patients undergoing preoxygenation without CPAP will be included

In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal CO2 value in this order will be recorded.

Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation and after intubation.

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Turkey
      • Ankara, Turkey
        • Diskapi Yildirim Beyazit Training Research Hospital

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion Criteria:

    1. Patients between the ages of 20 and 50 years
    2. American Society of Anesthesiologists I, II or III
    3. Patients with body mass index of 40 and over

Exclusion Criteria:

  1. cardiopulmonary disease
  2. patients with previous abdominal or thoracic surgery or cerebrovascular disease
  3. story of intracranial hypertension or epilepsy
  4. patients with a story of difficult tracheal intubation

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CPAP
During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O. The process will continue until the end-tidal O2 concentration ≥ 90% is removed.
Other: CPAP preoxygenation
During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
No Intervention: standard preoxygenation
During the preoxygenation, the ventilator device will be put in spontaneous mode and the procedure will continue until the End-tidal O2 concentration ≥90% is removed without additional pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of desaturation during intubation
Time Frame: 5 minutes
Prevent desaturation of the apnea period during endotracheal intubation in bariatric surgery
5 minutes
prevention of side effects of hypoxia
Time Frame: 10 minutes
hypoxia-induced arrhythmia hypotension tachycardia
10 minutes

Collaborators and Investigators

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

Sponsor

Ankara Diskapi Training and Research Hospital

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 (Actual)

March 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • preoxygenation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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