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NCT05395975 Clinical Trial

Different Preoxygenation Methods In Cesarean Section

Hypoxia Clinical Trial

Official title:
Assessment of Different Preoxygenation Methods With Oxygen Reserve Index In Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05395975
Other study ID # 2020/22-24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2021

Study information
Verified date November 2020
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 31, 2021
Est. primary completion date December 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Oxygen 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).

Locations
Country Name City State
Turkey Zonguldak Bülent Ecevit University Faculty of Medicine Zonguldak Kozlu

Sponsors (1)
Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preoxygenation Methods Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index During the surgery
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