AtelectasisNCT06658613
Pediatric Bronchoscopy and LUS
An observational study of Atelectasis and Atelectasis, Postoperative Pulmonary, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Rigid bronchoscopy is commonly used for diagnosing and treating lung and airway diseases, including foreign body removal. Patients often experience atelectasis post-procedure, which lung ultrasound (LUS) can effectively detect. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Atelectasis, Atelectasis, Postoperative Pulmonary
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 1 May 2025
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 1-17 year old pediatric patients who will undergo elective rigid bronchoscopy under general anesthesia by the pediatric surgery department at Marmara University Training and Research Hospital.
Who may be able to join
- Elective rigid bronchoscopy
- American Society of Anaesthesiologists (ASA) physical status I or II
Who cannot join
- Emergent rigid bronchoscopy
- ASA III or above
- Patients left intubated after the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, Istanbul, 34899
About this study
Official title: Atelectasis and Lung USG Scores in Pediatric Patients Undergoing Bronchoscopy
Rigid bronchoscopy is commonly used for diagnosing and treating lung and airway diseases, including foreign body removal. Patients often experience atelectasis post-procedure, which lung ultrasound (LUS) can effectively detect. LUS is a rapid, noninvasive imaging technique that provides real-time evaluation without the need for patient transportation. In this observational study, researchers will assess the incidence and severity of atelectasis in patients undergoing elective rigid bronchoscopy, comparing those who were intubated and awakened post-procedure with those who were not intubated. The study aims to determine whether intubation influences the development of atelectasis after bronchoscopy.
Read the detailed description
Rigid bronchoscopy has been used for many years in the diagnosis and treatment of various primary diseases of the lungs and airways, removal of tracheobronchial foreign bodies and therapeutic procedures for central airway pathologies. Most patients have atelectasis after the procedure. Lung ultrasound (LUS) has begun to take its place in clinical use as a new tool for the detection of both acute and chronical pathologies in the perioperative period and intensive care follow-up of patients. Its use is rapid, noninvasive, point-of-care, without radiation and no need patient transportation. The imaging pattern of atelectasis is similar to that of lung consolidation, and the B line image and loss of lung shear are considered typical findings. Atelectasis after a bronchoscopy procedure can be recognized with LUS. As standard procedure, after bronchoscopy, patients are given drugs (neostigmine or sugammadex) to reverse the effect of muscle relaxants and are allowed to wake up. During this time, patients are sometimes intubated until their respiratory function is fully restored and the patient wakes up. Which patient is intubated depends on factors such as the patient's comorbidities, lung capacity, the procedure performed and the clinician's preference. Intubation may reduce the development of atelectasis due to positive airway pressure. In this observational study, we aim to determine the frequency and degree of atelectasis in patients undergoing elective rigid bronchoscopy using lung ultrasound. Specifically, we will compare the frequency and degree of atelectasis in patients who were intubated and awakened after bronchoscopy and those who were awakened without intubation.
- Conditions
- Atelectasis, Atelectasis, Postoperative Pulmonary
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Patients not intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course. | |
| Group I | Patients intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis
Lung ultrasound score (LUS) will be used for the detection of atelectasis. Each lung will be evaluated separately and scores will be recorded. Scores will be obtained from 6 regions for each lung (anterior superior/inferior, middle superior/inferior, posterior superior/inferior) for a total of 12 regions for each patient. Scoring will be based on the 'B lines' pattern seen on LUS (B0, B1, B2, B3, indicating progressive atelectasis). A score of 0 to 3 points will be given for each lung field measured, for a total LUS of 0-36.
Measured: From the preinduction period in the operating theater to the postoperative recovery of the patient again in the operating theater.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start25 Oct 2024
- Primary completion1 May 2025
- Study completion1 May 2025
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
- Investigators
- Ruslan Abdullayev, Principal investigator, Marmara University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658613
- Sponsor's protocol ID
- 09.2024.870
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atelectasis and Lung USG Scores in Pediatric Patients Undergoing Bronchoscopy
- ClinicalTrials.gov ID
- NCT06658613
- Acronym / sponsor ID
- 09.2024.870
- Conditions
- Atelectasis, Atelectasis, Postoperative Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 26 Oct 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.
Rigid bronchoscopy is commonly used for diagnosing and treating lung and airway diseases, including foreign body removal. Patients often experience atelectasis post-procedure, which lung ultrasound (LUS) can effectively detect. LUS is a rapid, noninvasive imaging technique that provides real-time evaluation without the need for patient transportation. In this observational study, researchers will assess the incidence and severity of atelectasis in patients undergoing elective rigid bronchoscopy, comparing those who were intubated and awakened post-procedure with those who were not intubated. The study aims to determine whether intubation influences the development of atelectasis after bronchoscopy.
Detailed description
Rigid bronchoscopy has been used for many years in the diagnosis and treatment of various primary diseases of the lungs and airways, removal of tracheobronchial foreign bodies and therapeutic procedures for central airway pathologies. Most patients have atelectasis after the procedure. Lung ultrasound (LUS) has begun to take its place in clinical use as a new tool for the detection of both acute and chronical pathologies in the perioperative period and intensive care follow-up of patients. Its use is rapid, noninvasive, point-of-care, without radiation and no need patient transportation. The imaging pattern of atelectasis is similar to that of lung consolidation, and the B line image and loss of lung shear are considered typical findings. Atelectasis after a bronchoscopy procedure can be recognized with LUS. As standard procedure, after bronchoscopy, patients are given drugs (neostigmine or sugammadex) to reverse the effect of muscle relaxants and are allowed to wake up. During this time, patients are sometimes intubated until their respiratory function is fully restored and the patient wakes up. Which patient is intubated depends on factors such as the patient's comorbidities, lung capacity, the procedure performed and the clinician's preference. Intubation may reduce the development of atelectasis due to positive airway pressure. In this observational study, we aim to determine the frequency and degree of atelectasis in patients undergoing elective rigid bronchoscopy using lung ultrasound. Specifically, we will compare the frequency and degree of atelectasis in patients who were intubated and awakened after bronchoscopy and those who were awakened without intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | – | –Patients not intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course. |
| Group I | – | –Patients intubated at the end of the bronchoscopy during the neuromuscular block reversal and weaning course. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 1-17 year old pediatric patients who will undergo elective rigid bronchoscopy under general anesthesia by the pediatric surgery department at Marmara University Training and Research Hospital.
Key inclusion criteria (2 listed)
- Elective rigid bronchoscopy
- American Society of Anaesthesiologists (ASA) physical status I or II
Key exclusion criteria (3 listed)
- Emergent rigid bronchoscopy
- ASA III or above
- Patients left intubated after the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atelectasis
Time frame: From the preinduction period in the operating theater to the postoperative recovery of the patient again in the operating theater.
Lung ultrasound score (LUS) will be used for the detection of atelectasis. Each lung will be evaluated separately and scores will be recorded. Scores will be obtained from 6 regions for each lung (anterior superior/inferior, middle superior/inferior, posterior superior/inferior) for a total of 12 regions for each patient. Scoring will be based on the 'B lines' pattern seen on LUS (B0, B1, B2, B3, indicating progressive atelectasis). A score of 0 to 3 points will be given for each lung field measured, for a total LUS of 0-36.
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 10 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ruslan Abdullayev principal investigator
Marmara University Department of Anesthesiology and Reanimation
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 Atelectasis, Postoperative Pulmonary, run by Marmara 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 2 inclusion and 3 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 10 Jun 2025. 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?
Atelectasis (time frame: From the preinduction period in the operating theater to the postoperative recovery of the patient again in the operating theater.). 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 10 Jun 2025.