AtelectasisNCT03453762
The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children
A study testing recruitment maneuver and ultrasonography-guided recruitment maneuver in people with Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- recruitment maneuver and ultrasonography-guided recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2018to 1 Mar 2019
- Phase
- Interventional
- 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 Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who undergo surgery for more than 1 hour under general anesthesia
- Children under 6 years old
- American Society of Anesthesiologist Physical Status I or II
Who cannot join
- History of lung surgery
- Abnormal findings in chest x-ray
- Laparoscopic surgery
- Abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.
- Conditions
- Atelectasis
- Being tested
- recruitment maneuver, ultrasonography-guided recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuverProcedure or surgery
Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
ultrasonography-guided recruitment maneuverProcedure or surgery
Recruitment maneuver is guided by ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver group | Active comparator | After anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds. Receives: Procedure: recruitment maneuver |
| Lung ultrasonography group | Experimental | After anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography. Receives: Procedure: ultrasonography-guided recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative atelectasis
Postoperative atelectasis is measured using lung ultrasonography
Measured: within 1 hour after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start23 Mar 2018
- Primary completion20 Feb 2019
- Study completion1 Mar 2019
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 AtelectasisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453762
- Sponsor's protocol ID
- H1802-058-921
- Status last verified
- May 2019
- First submitted
- 27 Feb 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.
PubMed 32068572
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lung Recruitment Maneuver on Postoperative Atelectasis in Children - Effect of Ultrasonography Guided Recruitment
- ClinicalTrials.gov ID
- NCT03453762
- Acronym / sponsor ID
- H1802-058-921
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Mar 2018 (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.
The investigators compare the degree of atelectasis in recovery room between conventional recruitment maneuver and ultrasonography-guided lung recruitment during surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver group | Active comparator | Procedure: recruitment maneuverAfter anesthetic induction, recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds. |
| Lung ultrasonography group | Experimental | Procedure: ultrasonography-guided recruitment maneuverAfter anesthetic induction, recruitment maneuver is performed, being guided by ultrasonography. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who undergo surgery for more than 1 hour under general anesthesia
- Children under 6 years old
- American Society of Anesthesiologist Physical Status I or II
Key exclusion criteria (4 listed)
- History of lung surgery
- Abnormal findings in chest x-ray
- Laparoscopic surgery
- Abdominal surgery
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 |
|---|---|---|
| recruitment maneuverRecruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds. | Procedure or surgery | Recruitment maneuver group |
| ultrasonography-guided recruitment maneuverRecruitment maneuver is guided by ultrasonography. | Procedure or surgery | Lung ultrasonography group |
Primary outcome
Incidence of postoperative atelectasis
Time frame: within 1 hour after the end of surgery
Postoperative atelectasis is measured using lung ultrasonography
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 15 May 2019.
- Derived from this study: PubMed 32068572Lee JH, Choi S, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Effect of an ultrasound-guided lung recruitment manoeuvre on postoperative atelectasis in children: A randomised controlled trial. Eur J Anaesthesiol. 2020 Aug;37(8):719-727. doi: 10.1097/EJA.0000000000001175.
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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.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recruitment maneuver and ultrasonography-guided recruitment maneuver in people with Atelectasis, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 15 May 2019. 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 South Korea. 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 postoperative atelectasis (time frame: within 1 hour after the end of surgery). 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 NCT03453762, 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 15 May 2019.