The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery
1 other identifier
interventional
138
1 country
1
Brief Summary
Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedStudy Start
First participant enrolled
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2023
CompletedMay 12, 2022
May 1, 2022
5 years
September 20, 2018
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pulmonary complication
Performing lung ultrasound to evaluate if pulmonary complication is occurred
Immediately after entering PACU
Study Arms (2)
No alveolar recruitment maneuver
NO INTERVENTIONApplying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O
Alveolar recruitment maneuver
ACTIVE COMPARATORApplying 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
Interventions
Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation
Eligibility Criteria
You may qualify if:
- Adult patients, ASA I-II, scheduled to elective laparoscopic surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital, department of Anesthesia and pain
Seongnam, Gyenggo-do, 13620, South Korea
Related Publications (1)
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.
PMID: 38722838DERIVED
Study Officials
- STUDY DIRECTOR
Ah Young Oh, M.D., Ph. D
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 24, 2018
Study Start
October 4, 2018
Primary Completion
October 4, 2023
Study Completion
December 6, 2023
Last Updated
May 12, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share