Ventilator-driven Alveolar Recruitment Maneuver

NCT04258202 | Completed

• 1 other identifier: SMC2019-11-117-003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).

Conditions

Postoperative Atelectasis; Ventilator Lung; Atelectasis; Recruitment

Outcome Measures

Primary Outcomes (1)

• the change of Atelectasis volume

  electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)

  intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

Secondary Outcomes (5)

• the change of lung compliance value

  intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

• the change of arterial blood gas analysis

  intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

• the change of driving pressure value

  intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

• the change of peak pressure value

  intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery

• The difference of atelectasis

  at postoperative 30 minutes

Study Arms (2)

positive end expiratory pressure group

EXPERIMENTAL

Alveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. PEEP increased in a stepwise manner from 5 to 20 cmH2O, until plateau pressure 30 cmH2, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with positive end expiratory pressure (PEEP) 5cmH2O.

Other: Alveolar recruitment maneuver

tidal volume group

EXPERIMENTAL

Alveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. Tidal volume increased in steps of 4mL/kg of ideal body weight until plateau pressure 30 cmH2O, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with PEEP 5 cmH2O.

Other: Alveolar recruitment maneuver

Interventions

Alveolar recruitment maneuver OTHER

The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.

positive end expiratory pressure group; tidal volume group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who receive laparoscopic surgery in trendelenberg position

You may not qualify if:

• Patients who are simultaneously participating in other studies
• Patients who are scheduled to leave the intensive care unit after surgery
• Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test
• High risk in cardiovascular events (expected postoperative cardiovascular event \> 5%)
• Patients with emphysema confirmed by imaging test
• patients with obesity BMI \> 35 kg / m2

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 6, 2020
• Study Start: March 2, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 8, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-01

Locations

KR (1)