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CompletedNCT05395975Updated May 27, 2022

Different Preoxygenation Methods In Cesarean Section

An observational study in Hypoxia and Hyperoxia, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.

Sponsored by Zonguldak Bulent Ecevit University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hypoxia
  • Hyperoxia

Keywords

  • Oxygen Reserve Index
  • Preoxygenation
  • General Anesthesia
  • Cesarean Section
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 1 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceOxygen Reserve Index

    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).

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What researchers measure

Primary outcomes

  1. Preoxygenation Methods

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

    Time frame: During the surgery

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Study locations

1 site
  • Zonguldak Bülent Ecevit University Faculty of Medicine
    Zonguldak, Kozlu 67600, Turkey
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05395975
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
Sponsor
First posted
May 27, 2022
Start date
Dec 1, 2020
Primary completion
Dec 27, 2021
Completion
Dec 31, 2021
Last update
May 27, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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