NCT05395975

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

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

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

May 12, 2022

Last Update Submit

May 24, 2022

Conditions

HypoxiaHyperoxia

Keywords

Oxygen Reserve IndexPreoxygenationGeneral AnesthesiaCesarean Section

Outcome Measures

Primary Outcomes (1)

  • Preoxygenation Methods

    Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index

    During the surgery

Study Arms (2)

Group I

Preoxygenation with 100% oxygen for 3 minutes

Device: Oxygen Reserve Index

Group II

4 deep breaths with 100% oxygen in 30 seconds

Device: Oxygen Reserve Index

Interventions

Oxygen Reserve IndexDEVICE

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 IGroup II

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Faculty of Medicine

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypoxiaHyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 27, 2022

Study Start

December 1, 2020

Primary Completion

December 27, 2021

Study Completion

December 31, 2021

Last Updated

May 27, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Locations

TU(1)