The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03681236
• Collaborator: (none)
• Enrollment: 138
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 62.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pulmonary Complication	Procedure: Alveolar recruitment maneuver	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: The Effect of Alveolar Recruitment Maneuver on Postoperative Pulmonary Complications in Laparoscopic Surgery
• Actual Study Start Date: Oct 4, 2018
• Anticipated Primary Completion Date: Oct 4, 2023
• Anticipated Study Completion Date: Dec 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No alveolar recruitment maneuver Applying ventilation with tidal volume 6-8mL/kg (ideal body weight) and PEEP 5cmH₂O
Active Comparator: 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	Procedure: Alveolar recruitment maneuver; Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation

Outcome Measures

Primary Outcome Measures

1. Postoperative pulmonary complication [Immediately after entering PACU]

   Performing lung ultrasound to evaluate if pulmonary complication is occurred

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital, department of Anesthesia and pain	Seongnam	Gyenggo-do	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

• Study Director: Ah Young Oh, M.D., Ph. D, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEE YEA JI, Assistant professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT03681236
• Other Study ID Numbers: B1708-415-302
• First Posted: Sep 24, 2018
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by LEE YEA JI, Assistant professor, Seoul National University Bundang Hospital: Alveolar recruitment, laparoscopic surgery

Study Results

No Results Posted as of May 12, 2022