- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05509764
The Effect of Oxygen Therapy on Atelectasis
August 22, 2022 updated by: Manolya ALKAN CANITEZ, Zonguldak Bulent Ecevit University
Evaluation of Oxygen Threapy by Lung Ultrasound and Oxygen Reserve Index in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey, 67600
- Zonguldak Bülent Ecevit University medicine faculty
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Zonguldak, Kozlu, Turkey, 67600
- Manolya Alkan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 47 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
parturients who underwent cesarean section under spinal anesthesia
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
group 0
control group
|
determination of atelectasis by lung ultrasound score
|
group 3
3 Lt/min Oxygen therapy via nasal cannula
|
determination of atelectasis by lung ultrasound score
|
group 6
6 Lt/min Oxygen therapy via Simple face mask
|
determination of atelectasis by lung ultrasound score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
atelectasis
Time Frame: during the surgery
|
measuring atelectasis due to oxygen therapy
|
during the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
APGAR score
Time Frame: 1st and 5th min after delivery
|
baby status after delivery
|
1st and 5th min after delivery
|
hypotension
Time Frame: during surgery
|
maternal hypotension
|
during surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2021
Primary Completion (ACTUAL)
March 1, 2022
Study Completion (ACTUAL)
August 1, 2022
Study Registration Dates
First Submitted
August 18, 2022
First Submitted That Met QC Criteria
August 18, 2022
First Posted (ACTUAL)
August 22, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/02 (Avrasya University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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