NCT03903003

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

April 3, 2019

Last Update Submit

March 13, 2021

Conditions

Cesarean Delivery Affecting Newborn

Keywords

high flow nasal oxygen (POİNT)

Outcome Measures

Primary Outcomes (1)

  • durations of stay

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

    24 hours

Study Arms (2)

preoxygenation mask applied to the cesarean

ACTIVE COMPARATOR

In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.

Device: Face mask

high flow nasal oxygenation applied to the ceserian

ACTIVE COMPARATOR

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)

Interventions

high flow nasal oxygen device (POİNT)DEVICE

With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.

high flow nasal oxygenation applied to the ceserian
Face maskDEVICE

In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.

preoxygenation mask applied to the cesarean

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Derince Education and Research Hospital

Kocaeli, 41400, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mehmet Yılmaz

    HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical researcher

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

January 1, 2019

Primary Completion

March 8, 2019

Study Completion

December 31, 2019

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

TU(1)