The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

NCT ID: NCT03681236

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2023-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pulmonary Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No alveolar recruitment maneuver

Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O

Group Type NO_INTERVENTION

No interventions assigned to this group

Alveolar recruitment maneuver

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

Group Type ACTIVE_COMPARATOR

Alveolar recruitment maneuver

Intervention Type PROCEDURE

Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alveolar recruitment maneuver

Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients, ASA I-II, scheduled to elective laparoscopic surgery

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LEE YEA JI

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ah Young Oh, M.D., Ph. D

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Bundang Hospital, department of Anesthesia and pain

Seongnam, Gyenggo-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sun Woo Nam, M.D

Role: CONTACT

+82-31-787-7499

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sun Woo Nam

Role: primary

82-31-787-7499

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38722838 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B1708-415-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cerebral Oxygenation After Lung Resection
NCT01183871 COMPLETED PHASE1