- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591327
Atelectasis by Lung Ultrasonography in Cesarean Sections
October 16, 2020 updated by: ERHAN KARACA, Derince Training and Research Hospital
Determination of the Effects of General Anesthesia and Spinal Anesthesia Applied in Elective Cesarean Operations on Postoperative Atelectasis by Lung Ultrasonography
In this study aimed to demonstrate that atelectasis developing in the perioperative period of patients undergoing elective cesarean surgery with spinal or general anesthesia methods using lung ultrasound.
After Preoperative lung ultrasounds of patients is done, the cesarean operation will be completed with spinal or general anesthesia.
In the postoperative period, control lung ultrasounds will be performed and the ultrasound results will be compared in terms of atelectasis in both groups.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
46
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
-
-
-
Kocaeli, Turkey, 41900
- Kocaeli Derince Train and Research Hospital
-
-
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 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.
Description
Inclusion Criteria:
- Between 18-40 years
- 37-40 weeks pregnant
- ASA II because of pregnancy
Exclusion Criteria:
- Emergency cesarean sections
- who refuse to participate in the study
- with chronic disease
- Smoker
- with chest deformity
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
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
general anesthesia
|
Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded.
The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression.
In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10.
In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is> 9, lung ultrasonography will be performed.
The degree of atelectasis will be determined according to the modified LUS score.
|
|
spinal anesthesia
|
Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded.
The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression.
In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10.
In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is> 9, lung ultrasonography will be performed.
The degree of atelectasis will be determined according to the modified LUS score.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of the postoperative atelectasis
Time Frame: two months
|
two months
|
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)
August 1, 2020
Primary Completion (Actual)
September 14, 2020
Study Completion (Actual)
September 16, 2020
Study Registration Dates
First Submitted
October 4, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 16, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1258-9377
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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