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

Sponsor
Kocaeli Derince Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03903003
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
12
Actual Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: high flow nasal oxygen device (POİNT)
  • Device: Face mask
 N/A

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 Design

Study Type:
Interventional
Actual 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 :
Jan 1, 2019
Actual Primary Completion Date :
Mar 8, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. durations of stay [24 hours]

    compare the durations of stay in the intensive care unit and in hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli Derince Education and Research Hospital Kocaeli Turkey 41400

Sponsors and Collaborators

  • Kocaeli Derince Education and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 4, 2019
Last Update Posted:
Mar 16, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EMİNE YURT, clinical researcher, Kocaeli Derince Education and Research Hospital
high flow nasal oxygen (POİNT)

Study Results

No Results Posted as of Mar 16, 2021