The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pulmonary Complication
• Intervention / Treatment: Procedure: Alveolar recruitment maneuver

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sun Woo Nam, M.D; Phone Number: +82-31-787-7499; Email: nsw116@snubh.org

Study Locations

• Korea, Republic of
  • Gyenggo-do
    • Seongnam, Gyenggo-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital, department of Anesthesia and pain
      • Contact: Sun Woo Nam; Phone Number: 82-31-787-7499; Email: nsw116@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pulmonary complication	Performing lung ultrasound to evaluate if pulmonary complication is occurred	Immediately after entering PACU

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Anticipated): October 4, 2023
• Study Completion (Anticipated): December 6, 2023

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Alveolar recruitment, laparoscopic surgery
• Other Study ID Numbers: B1708-415-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No