Different Preoxygenation Methods In Cesarean Section

May 24, 2022 updated by: Zonguldak Bulent Ecevit University

Assessment of Different Preoxygenation Methods With Oxygen Reserve Index In Cesarean Section

The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI).

After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen status of the patients will be compared with ORI monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Faculty of Medicine

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients aged 18-45 who had cesarean section under general anesthesia

Description

Inclusion Criteria:

  • The average operation time is 30 minutes-1.5 hours.
  • ASA II risk class
  • All pregnant women with a gestational week >36

Exclusion Criteria:

  • preeclampsia
  • eclampsia
  • fetal distress
  • morbid obesity
  • a history of malignant hyperthermia
  • opioid sensitivity
  • alcohol or drug addiction
  • congestive heart failure
  • chronic obstructive pulmonary disease
  • coronary artery disease
  • anemia, liver and kidney disease
  • hypovolemia, hypotension, sepsis
  • Those who are allergic to the drugs used in the study and who are suspected of difficult 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Preoxygenation with 100% oxygen for 3 minutes
Device: Oxygen Reserve Index
It is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg).
Group II
4 deep breaths with 100% oxygen in 30 seconds
Device: Oxygen Reserve Index
It is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoxygenation Methods
Time Frame: During the surgery
Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index
During the surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit University

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)

December 1, 2020

Primary Completion (Actual)

December 27, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/22-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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