Atelectasis; Due to AnesthesiaNCT05381701
Effects of Different Flow Anesthesia on Atelectasis
An observational study of Atelectasis; Due to Anesthesia and General Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis; Due to Anesthesia, General Anesthesia, Low- Flow Anesthesia
- What is being tested?
- Lung Ultrasound Score
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I-II septoplasty and rhinoplasty patients aged 18-65 years
Who may be able to join
- operation time 2-5 hours
- elective septoplasty and rhinoplasty
- ASA I-II
Who cannot join
- morbid obesity
- malignant hyperthermia
- opioid sensitivity
- alcohol or drug addiction
- congestive heart failure
- chronic obstructive pulmonary disease
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- coronary artery disease
- anemia
- liver and kidney diseases
- pregnancy
- breast-feeding
- history of allergy to drugs used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Faculty of Medicine
Zonguldak, Kozlu, 67600
About this study
Official title: Evaluation Of Peroperative Atelectasis In Minimal, Low And Medium Flow Anesthesia By Lung Ultrasound Score
Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score.
- Conditions
- Atelectasis; Due to Anesthesia, General Anesthesia, Low- Flow Anesthesia, Minimal Flow Anesthesia
- Being tested
- Lung Ultrasound Score
- Keywords
- Lung Ultrasound Score, Minimal Flow Anesthesia, Atelectasis
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound ScoreProcedure or surgery
Measuring the atelectasis area by ultrasound guidance from 12 different regions of the lung
| Study group | Role | What they receive |
|---|---|---|
| Group I | Minimal Flow Anesthesia (0.25L/dk oxygen, 0,25 L/min air) Receives: Procedure: Lung Ultrasound Score | |
| Group II | Low Flow Anesthesia (0.5L/dk oxygen, 0,5 L/min air) Receives: Procedure: Lung Ultrasound Score | |
| Group III | Medium Flow Anesthesia (1L/dk oxygen, 1 L/min air Receives: Procedure: Lung Ultrasound Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of lung ultrasound score
Effect of different flow anesthesia on lung ultrasound score
Measured: Change from Baseline and 30 minute after emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis; Due to AnesthesiaStudies 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)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Ozturk, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381701
- Sponsor's protocol ID
- 2020/25-6
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 19 May 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Peroperative Atelectasis In Minimal, Low And Medium Flow Anesthesia By Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT05381701
- Acronym / sponsor ID
- 2020/25-6
- Conditions
- Atelectasis; Due to Anesthesia, General Anesthesia, Low- Flow Anesthesia, Minimal Flow Anesthesia
- Keywords
- Lung Ultrasound Score, Minimal Flow Anesthesia, Atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 May 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.
Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Lung Ultrasound ScoreMinimal Flow Anesthesia (0.25L/dk oxygen, 0,25 L/min air) |
| Group II | – | Procedure: Lung Ultrasound ScoreLow Flow Anesthesia (0.5L/dk oxygen, 0,5 L/min air) |
| Group III | – | Procedure: Lung Ultrasound ScoreMedium Flow Anesthesia (1L/dk oxygen, 1 L/min air |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-II septoplasty and rhinoplasty patients aged 18-65 years
Key inclusion criteria (3 listed)
- operation time 2-5 hours
- elective septoplasty and rhinoplasty
- ASA I-II
Key exclusion criteria (12 listed)
- morbid obesity
- malignant hyperthermia
- opioid sensitivity
- alcohol or drug addiction
- congestive heart failure
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 ScoreMeasuring the atelectasis area by ultrasound guidance from 12 different regions of the lung | Procedure or surgery | Group I, Group II, Group III |
Primary outcome
assessment of lung ultrasound score
Time frame: Change from Baseline and 30 minute after emergence
Effect of different flow anesthesia on lung ultrasound score
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 May 2022.
- Individual participant dataSharing planned: Yes
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; Due to Anesthesia and General Anesthesia, run by Zonguldak Bulent Ecevit University 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 12 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 May 2022. 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?
assessment of lung ultrasound score (time frame: Change from Baseline and 30 minute after emergence). 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 May 2022.