Postoperative Pulmonary ComplicationNCT03681236
The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery
A study testing Alveolar recruitment maneuver in people with Postoperative Pulmonary Complication, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pulmonary Complication
- What is being tested?
- Alveolar recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2018to 6 Dec 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, ASA I-II, scheduled to elective laparoscopic surgery
Who cannot join
- Chronic lung disease
- Cardiovascular disease
- ASA class ≥ III
- Receiving ventilation therapy or received within 6 months
- Refusal of participation in study or failure in informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital, department of Anesthesia and pain
Seongnam, Gyenggo-do, 13620
Sun Woo Nam, 82-31-787-7499, nsw116@snubh.org
About this study
Official title: The Effect of Alveolar Recruitment Maneuver on Postoperative Pulmonary Complications in Laparoscopic Surgery
Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery
Read the detailed description
Comparing ventilation with PEEP (positive end expiratory pressure) to ventilation with PEEP and alveolar recruitment, we expect that alveolar recruitment will reduce the incidence of pulmonary complication in patients undergo laparoscopic surgery. Ventilation with only PEEP is generally not enough to reduce postoperative pulmonary complication effectively.
- Conditions
- Postoperative Pulmonary Complication
- Being tested
- Alveolar recruitment maneuver
- Keywords
- Alveolar recruitment, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitment maneuverProcedure or surgery
Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation
| Study group | Role | What they receive |
|---|---|---|
| No alveolar recruitment maneuver | No intervention | Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O |
| Alveolar recruitment maneuver | Active comparator | Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O. In addition to this, performing alveolar recruitment maneuver at 2 moments: before surgical incision, end of pneumoperitoneum Receives: Procedure: Alveolar recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complication
Performing lung ultrasound to evaluate if pulmonary complication is occurred
Measured: Immediately after entering PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start4 Oct 2018
- Primary completion4 Oct 2023 (estimated)
- Study completion6 Dec 2023 (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 Postoperative Pulmonary ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YEA JI, Seoul National University Bundang Hospital
- Investigators
- Ah Young Oh, M.D., Ph. D, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681236
- Sponsor's protocol ID
- B1708-415-302
- Status last verified
- May 2022
- First submitted
- 20 Sep 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bae YK, Nam SW, Oh AY, Kim BY, Koo BW, Han J, Yim S. Effect of the alveolar recruitment maneuver during laparoscopic colorectal surgery on postoperative pulmonary complications: A randomized controlled trial. PLoS One. 2024 May 9;19(5):e0302884. doi: 10.1371/journal.pone.0302884. eCollection 2024.
PubMed 38722838
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alveolar Recruitment Maneuver on Postoperative Pulmonary Complications in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03681236
- Acronym / sponsor ID
- B1708-415-302
- Conditions
- Postoperative Pulmonary Complication
- Keywords
- Alveolar recruitment, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 4 Oct 2023 (estimated)
- Study completion
- 6 Dec 2023 (estimated)
- First posted
- 24 Sep 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.
Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery
Detailed description
Comparing ventilation with PEEP (positive end expiratory pressure) to ventilation with PEEP and alveolar recruitment, we expect that alveolar recruitment will reduce the incidence of pulmonary complication in patients undergo laparoscopic surgery. Ventilation with only PEEP is generally not enough to reduce postoperative pulmonary complication effectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No alveolar recruitment maneuver | No intervention | –Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O |
| Alveolar recruitment maneuver | Active comparator | Procedure: Alveolar recruitment maneuverApplying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O. In addition to this, performing alveolar recruitment maneuver at 2 moments: before surgical incision, end of pneumoperitoneum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, ASA I-II, scheduled to elective laparoscopic surgery
Key exclusion criteria (5 listed)
- Chronic lung disease
- Cardiovascular disease
- ASA class ≥ III
- Receiving ventilation therapy or received within 6 months
- Refusal of participation in study or failure in informed consent
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 |
|---|---|---|
| Alveolar recruitment maneuverApplying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation | Procedure or surgery | Alveolar recruitment maneuver |
Primary outcome
Postoperative pulmonary complication
Time frame: Immediately after entering PACU
Performing lung ultrasound to evaluate if pulmonary complication is occurred
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 38722838Bae YK, Nam SW, Oh AY, Kim BY, Koo BW, Han J, Yim S. Effect of the alveolar recruitment maneuver during laparoscopic colorectal surgery on postoperative pulmonary complications: A randomized controlled trial. PLoS One. 2024 May 9;19(5):e0302884. doi: 10.1371/journal.pone.0302884. eCollection 2024.
- 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.
Ah Young Oh, M.D., Ph. D study director
Seoul National University Bundang 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 Alveolar recruitment maneuver in people with Postoperative Pulmonary Complication, run by Seoul National University Bundang 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 1 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 12 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Woo Nam, M.D (+82-31-787-7499, nsw116@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complication (time frame: Immediately after entering PACU). 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 NCT03681236, 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 12 May 2022.