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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903003
Recruitment Status : Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
EMİNE YURT, Kocaeli Derince Education and Research Hospital

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

Condition or disease Intervention/treatment Phase
Cesarean Delivery Affecting Newborn Device: high flow nasal oxygen device (POİNT) Device: Face mask Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : November 8, 2020
Estimated Study Completion Date : December 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




Primary Outcome Measures :
  1. durations of stay [ Time Frame: 24 hours ]
    compare the durations of stay in the intensive care unit and in hospital



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903003


Locations
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Turkey
Kocaeli Derince Education and Research Hospital
Kocaeli, Turkey, 41400
Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Investigators
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Study Director: Mehmet Yılmaz HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL
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Responsible Party: EMİNE YURT, clinical researcher, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03903003    
Other Study ID Numbers: KIA 2018/506
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMİNE YURT, Kocaeli Derince Education and Research Hospital:
high flow nasal oxygen (POİNT)