Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

March 13, 2021 updated by: EMİNE YURT, Kocaeli Derince Education and Research Hospital

In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who will undergo caesarean section under general anesthesia will be included in the study.

In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.

Study Type

Interventional

Enrollment (Actual)

100

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
      • Kocaeli, Turkey, 41400
        • Kocaeli Derince Education and 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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • over 18 years old;
  • Patients undergoing elective ceserian operation

Exclusion Criteria:

  • Patients who refuse to participate in the study;
  • Patients under emergency conditions.

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: preoxygenation mask applied to the cesarean
In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.
Device: Face mask
In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.
ACTIVE_COMPARATOR: high flow nasal oxygenation applied to the ceserian
In order to protect the mother from hypoxia, preoxygenation is performed with high flow nasal oxygenation mask before induction of anesthesia.
Device: high flow nasal oxygen device (POİNT)
With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
durations of stay
Time Frame: 24 hours
compare the durations of stay in the intensive care unit and in hospital
24 hours

Collaborators and Investigators

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

Sponsor

Kocaeli Derince Education and Research Hospital

Investigators

  • Study Director: Mehmet Yılmaz, HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL

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)

January 1, 2019

Primary Completion (ACTUAL)

March 8, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KIA 2018/506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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