Atelectasis, Postoperative PulmonaryNCT06358027
Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis
An observational study of Atelectasis, Postoperative Pulmonary, run by Dokuz Eylul University.
Trial summary
In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary
- What is being tested?
- lung ultrasound
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2024to 30 Apr 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients 18 years of age or older and American Society of Anesthesiologists (ASA) physical status I and III who were scheduled for general anesthesia were included in this prospective observational study.
Who may be able to join
- Patients undergoing general anesthesia with supine position
- Endotracheal intubations and mechanical ventilation during general anesthesia
- Operation time is more than 2 hours
Who cannot join
- Patients who will undergo surgical intervention under emergency conditions
- Pregnancy
- Upper respiratory tract disease in the last 3 weeks
- Previous lung surgery
- Advanced cardiac and/or pleural lung disease and chest wall deformity, and primary or metastatic lung cancer
About this study
Official title: Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis by Lung Ultrasonography: A Prospective Observational Study
In our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis.
Read the detailed description
Postoperative atelectasis is one of the most common pulmonary complications seen in surgical patients. Postoperative pulmonary complications and possible respiratory side effects have long been associated with anesthesia. Pulmonary complications are an important cause of morbidity and mortality in the postoperative period. The incidence of postoperative pulmonary complications due to long-term anesthesia varies between 5% and 80%, depending on the patient population, the surgery performed, and the criteria used to define the complication. It is known that the recovery period makes a significant contribution to the total amount of postoperative atelectasis. Spontaneously breathing patients are under the influence of anesthetic agents and neuromuscular blockers and cannot regain their functional residual capacity. For this reason, it is emphasized that atelectasis may develop in the postoperative period in cases whose anesthesia application is terminated by applying a spontaneous breathing period. Pressure support ventilation (PSV) is widely used for ventilator weaning in the intensive care unit (ICU) and has recently been available on anesthesia machines.
It is expected that the use of lung ultrasonography in operating rooms can reduce the complications that may develop in the postoperative period with evidence-based detection and early postoperative detection of atelectasis in the early postoperative period.
In this study, it was aimed to compare the effect of pre-extubation ventilation mode applied by anesthesia practitioners with ultrasound in the postoperative period on the frequency of atelectasis in adult patients who underwent surgery and whose lungs were evaluated as normal by ultrasound in the preoperative observation room. Modified LUS scores were used as lung ultrasonography evaluation criteria in the study.
- Conditions
- Atelectasis, Postoperative Pulmonary
- Being tested
- lung ultrasound
- Keywords
- Lung Ultrasonography, Atelectasis, Postoperative Pulmonary Complications, Pressure Support Ventilation
- 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 ultrasoundDiagnostic test
Also called Modified Transthoracic Ultrasound Scoring System
The patients included in the study underwent lung imaging with lung ultrasound score twice, in the preoperative preparation room and in the postoperative recovery unit.Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. In our study, we will use the modified LUS scoring, which has been shown to be more sensitive in the diagnosis of postoperative atelectasis in the recovery unit, based on existing literature reviews. The degree of the atelectasis will be determined according to do modified lung ultrasound score. Lung ultrasound score imaging of all patients was performed by the same anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| pressure support ventilation group | when the patients were ready for extubation, anesthesia was terminated by one of the selected pressure support ventilation Receives: Diagnostic Test: lung ultrasound | |
| manual ventilation group | when the patients were ready for extubation, anesthesia was terminated by one of the selected manual ventilation wake-up methods at the initiative of the relevant anesthesiologist. Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Transthoracic Ultrasound Score
Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. While the anterior and lateral regions were examined in the supine position by placing the probe perpendicular to the thoracic wall and longitudinal in the intercostal spaces with the bat sign displayed, especially the posterior regions close to the diaphragm were examined by placing the probe transversely in the intercostal spaces by turning the patient opposite. According to the systematic LUS protocol, each patient was evaluated for approximately 10-15 minutes and optimum images were obtained.Each area was scored on a scale of 0-3 according to the degree of atelectasis, and a total score between 0 (normal lung ventilation image) and 36 (total loss of ventilation) was calculated.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start5 Apr 2024 (estimated)
- Primary completion21 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atelectasis, Postoperative PulmonaryStudies 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
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Otlu, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358027
- Sponsor's protocol ID
- DokuzEU-ACC-BOtlu-01
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biyikoglu BO, Yurtl BS, Hanci V, Biyikoglu AS. Comparison of pressure support and manual ventilation modes during anaesthesia emergence on postoperative atelectasis using lung ultrasonography: A prospective cohort study. J Pak Med Assoc. 2026 May;76(5):646-651. doi: 10.47391/JPMA.22711.
PubMed 42261006
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Ventilation Modes Used During Anesthesia Awakening on the Frequency of Postoperative Atelectasis by Lung Ultrasonography: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06358027
- Acronym / sponsor ID
- DokuzEU-ACC-BOtlu-01
- Conditions
- Atelectasis, Postoperative Pulmonary
- Keywords
- Lung Ultrasonography, Atelectasis, Postoperative Pulmonary Complications, Pressure Support Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (estimated)
- Primary completion
- 21 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 10 Apr 2024 (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 our study, we aimed to detect atelectasis developing in patients undergoing surgery under general anesthesia using transthoracic lung ultrasonography and to investigate the effect of ventilation methods used during recovery from anesthesia on the formation of postoperative atelectasis.
Detailed description
Postoperative atelectasis is one of the most common pulmonary complications seen in surgical patients. Postoperative pulmonary complications and possible respiratory side effects have long been associated with anesthesia. Pulmonary complications are an important cause of morbidity and mortality in the postoperative period. The incidence of postoperative pulmonary complications due to long-term anesthesia varies between 5% and 80%, depending on the patient population, the surgery performed, and the criteria used to define the complication. It is known that the recovery period makes a significant contribution to the total amount of postoperative atelectasis. Spontaneously breathing patients are under the influence of anesthetic agents and neuromuscular blockers and cannot regain their functional residual capacity. For this reason, it is emphasized that atelectasis may develop in the postoperative period in cases whose anesthesia application is terminated by applying a spontaneous breathing period. Pressure support ventilation (PSV) is widely used for ventilator weaning in the intensive care unit (ICU) and has recently been available on anesthesia machines.
It is expected that the use of lung ultrasonography in operating rooms can reduce the complications that may develop in the postoperative period with evidence-based detection and early postoperative detection of atelectasis in the early postoperative period.
In this study, it was aimed to compare the effect of pre-extubation ventilation mode applied by anesthesia practitioners with ultrasound in the postoperative period on the frequency of atelectasis in adult patients who underwent surgery and whose lungs were evaluated as normal by ultrasound in the preoperative observation room. Modified LUS scores were used as lung ultrasonography evaluation criteria in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pressure support ventilation group | – | Diagnostic Test: lung ultrasoundwhen the patients were ready for extubation, anesthesia was terminated by one of the selected pressure support ventilation |
| manual ventilation group | – | Diagnostic Test: lung ultrasoundwhen the patients were ready for extubation, anesthesia was terminated by one of the selected manual ventilation wake-up methods at the initiative of the relevant anesthesiologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients 18 years of age or older and American Society of Anesthesiologists (ASA) physical status I and III who were scheduled for general anesthesia were included in this prospective observational study.
Key inclusion criteria (3 listed)
- Patients undergoing general anesthesia with supine position
- Endotracheal intubations and mechanical ventilation during general anesthesia
- Operation time is more than 2 hours
Key exclusion criteria (5 listed)
- Patients who will undergo surgical intervention under emergency conditions
- Pregnancy
- Upper respiratory tract disease in the last 3 weeks
- Previous lung surgery
- Advanced cardiac and/or pleural lung disease and chest wall deformity, and primary or metastatic lung cancer
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 ultrasoundAlso: Modified Transthoracic Ultrasound Scoring SystemThe patients included in the study underwent lung imaging with lung ultrasound score twice, in the preoperative preparation room and in the postoperative recovery unit.Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. In our study, we will use the modified LUS scoring, which has been shown to be more sensitive in the diagnosis of postoperative atelectasis in the recovery unit, based on existing literature reviews. The degree of the atelectasis will be determined according to do modified lung ultrasound score. Lung ultrasound score imaging of all patients was performed by the same anesthesiologist. | Diagnostic test | manual ventilation group, pressure support ventilation group |
Primary outcome
Modified Transthoracic Ultrasound Score
Time frame: two weeks
Both lungs were determined as anterior and posterior axillary lines as anatomical markers and divided into a total of 12 regions, 4 in the anterior thoracic wall, 4 in the lateral wall, and 4 in the posterior region. While the anterior and lateral regions were examined in the supine position by placing the probe perpendicular to the thoracic wall and longitudinal in the intercostal spaces with the bat sign displayed, especially the posterior regions close to the diaphragm were examined by placing the probe transversely in the intercostal spaces by turning the patient opposite. According to the systematic LUS protocol, each patient was evaluated for approximately 10-15 minutes and optimum images were obtained.Each area was scored on a scale of 0-3 according to the degree of atelectasis, and a total score between 0 (normal lung ventilation image) and 36 (total loss of ventilation) was calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 42261006Biyikoglu BO, Yurtl BS, Hanci V, Biyikoglu AS. Comparison of pressure support and manual ventilation modes during anaesthesia emergence on postoperative atelectasis using lung ultrasonography: A prospective cohort study. J Pak Med Assoc. 2026 May;76(5):646-651. doi: 10.47391/JPMA.22711.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atelectasis, Postoperative Pulmonary, run by Dokuz Eylul University.
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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Modified Transthoracic Ultrasound Score (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358027, which also lists 1 linked publication.
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 10 Apr 2024.