AtelectasisNCT04591327
Atelectasis by Lung Ultrasonography in Cesarean Sections
An observational study of Atelectasis and Cesarean Section, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Cesarean Section
- What is being tested?
- The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 16 Sep 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.
Who may be able to join
- Between 18-40 years
- 37-40 weeks pregnant
- ASA II because of pregnancy
Who cannot join
- Emergency cesarean sections
- who refuse to participate in the study
- with chronic disease
- Smoker
- with chest deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Train and Research Hospital
Kocaeli, 41900
About this study
Official title: 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.
- Conditions
- Atelectasis, Cesarean Section
- Being tested
- The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean SectionsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia | Not described Receives: Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections | |
| spinal anesthesia | Not described Receives: Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of the postoperative atelectasis
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Aug 2020
- Primary completion14 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERHAN KARACA, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591327
- Sponsor's protocol ID
- U1111-1258-9377
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects of General Anesthesia and Spinal Anesthesia Applied in Elective Cesarean Operations on Postoperative Atelectasis by Lung Ultrasonography
- ClinicalTrials.gov ID
- NCT04591327
- Acronym / sponsor ID
- U1111-1258-9377
- Conditions
- Atelectasis, Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general anesthesia | – | Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections |
| spinal anesthesia | – | Procedure: The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.
Key inclusion criteria (3 listed)
- Between 18-40 years
- 37-40 weeks pregnant
- ASA II because of pregnancy
Key exclusion criteria (5 listed)
- Emergency cesarean sections
- who refuse to participate in the study
- with chronic disease
- Smoker
- with chest deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean SectionsPreoperative 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. | Procedure or surgery | general anesthesia, spinal anesthesia |
Primary outcome
incidence of the postoperative atelectasis
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis and Cesarean Section, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of the postoperative atelectasis (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.