AtelectasisNCT05509764
The Effect of Oxygen Therapy on Atelectasis
An observational study of Atelectasis and Cesarean Section, run by Zonguldak Bulent Ecevit University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Cesarean Section, Hypotension
- What is being tested?
- lung ultrasound score
- How many people
- 1 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Aug 2022
- 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 47 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: parturients who underwent cesarean section under spinal anesthesia
Who may be able to join
- 18-50 years old
- ASA I-II
- Patients scheduled for elective cesarean section under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Manolya Alkan
Zonguldak, Kozlu, 67600
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: 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.
- Conditions
- Atelectasis, Cesarean Section, Hypotension
- Being tested
- lung ultrasound score
- Keywords
- Atelectasis, lung ultrasound, oxygen reserve index, cesarean section
- Medical subject headings
- Pulmonary Atelectasis, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound scoreDiagnostic test
determination of atelectasis by lung ultrasound score
| Study group | Role | What they receive |
|---|---|---|
| group 0 | control group Receives: Diagnostic Test: lung ultrasound score | |
| group 3 | 3 Lt/min Oxygen therapy via nasal cannula Receives: Diagnostic Test: lung ultrasound score | |
| group 6 | 6 Lt/min Oxygen therapy via Simple face mask Receives: Diagnostic Test: lung ultrasound score |
What is being measured
The primary outcome is the main question the study is designed to answer.
atelectasis
measuring atelectasis due to oxygen therapy
Measured: during the surgery
Secondary outcomes (2)
APGAR score
baby status after delivery
Measured: 1st and 5th min after delivery
hypotension
maternal hypotension
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 May 2021
- Primary completion1 Mar 2022
- Study completion1 Aug 2022
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
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manolya ALKAN CANITEZ, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509764
- Sponsor's protocol ID
- 2021/02
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygen Threapy by Lung Ultrasound and Oxygen Reserve Index in Patients Undergoing Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05509764
- Acronym / sponsor ID
- 2021/02
- Conditions
- Atelectasis, Cesarean Section, Hypotension
- Keywords
- Atelectasis, lung ultrasound, oxygen reserve index, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 22 Aug 2022 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 0 | – | Diagnostic Test: lung ultrasound scorecontrol group |
| group 3 | – | Diagnostic Test: lung ultrasound score3 Lt/min Oxygen therapy via nasal cannula |
| group 6 | – | Diagnostic Test: lung ultrasound score6 Lt/min Oxygen therapy via Simple face mask |
Who may qualify
- Ages
- 18 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- parturients who underwent cesarean section under spinal anesthesia
Key inclusion criteria (3 listed)
- 18-50 years old
- ASA I-II
- Patients scheduled for elective cesarean section under spinal anesthesia
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| lung ultrasound scoredetermination of atelectasis by lung ultrasound score | Diagnostic test | group 0, group 3, group 6 |
Primary outcome
atelectasis
Time frame: during the surgery
measuring atelectasis due to oxygen therapy
2 secondary outcomes
APGAR score
Time frame: 1st and 5th min after delivery
hypotension
Time frame: during surgery
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 26 Aug 2022.
- Individual participant dataSharing planned: Yes
Related trials for Atelectasis
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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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.
2 sites 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 Zonguldak Bulent Ecevit University at 2 sites 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 1 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 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
atelectasis (time frame: during the surgery). 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 26 Aug 2022.