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NCT05509764 Clinical Trial

The Effect of Oxygen Therapy on Atelectasis

Hypotension Clinical Trial

Official title:
Evaluation of Oxygen Threapy by Lung Ultrasound and Oxygen Reserve Index in Patients Undergoing Cesarean Section Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05509764
Other study ID # 2021/02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date August 1, 2022

Study information
Verified date August 2022
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the functional residual capacity and may increase the closure volume and predispose the pregnant woman to airway closure, leading to atelectasis. The development of atelectasis due to dermatomes retained in spinal anesthesia and intraoperative supine position may increase further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen reserve index.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date August 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 47 Years
Eligibility Inclusion Criteria: - 18-50 years old - ASA I-II - Patients scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: - alcohol or drug addiction, chronic obstructive pulmonary disease, cardiovascular disease, smokers anemia, liver or kidney disease, coagulation disorders allergic to anesthetic agents, sepsis or bacterial infection, body temperature is below 35°C and above 38°C Multiple pregnancy Preoperative hypoxemia SpO2<94% Diabetes mellitus Hypertension Placenta previa Premature rupture of membranes Intrauterine growth retardation Preeclampsia-eclampsia-fetal distress Polyhydramnios Morbid obesity BMI>45

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• lung ultrasound score
determination of atelectasis by lung ultrasound score

Locations
Country Name City State
Turkey Manolya Alkan Zonguldak Kozlu
Turkey Zonguldak Bülent Ecevit University Medicine Faculty 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 atelectasis measuring atelectasis due to oxygen therapy during the surgery
Secondary APGAR score baby status after delivery 1st and 5th min after delivery
Secondary hypotension maternal hypotension during surgery
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