Ventilator-driven Alveolar Recruitment Maneuver

Not Applicable

Completed

• Conditions: Ventilator Lung; Postoperative Atelectasis; Atelectasis; Recruitment
• Interventions: Other: Alveolar recruitment maneuver

• Registration Number: NCT04258202
• Lead Sponsor: Samsung Medical Center

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).

Detailed Description

General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, 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, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration.

Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-06
• Study Start: 2020-03-02
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-08
• Last Update Submitted: 2020-11-08
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• patients who receive laparoscopic surgery in trendelenberg position

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
positive end expiratory pressure group	Alveolar recruitment maneuver	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.
tidal volume group	Alveolar recruitment maneuver	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.

Primary Outcome Measures

Name	Time	Method
the change of Atelectasis volume	intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery	electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)

Secondary Outcome Measures

Name	Time	Method
the change of driving pressure value	intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery	comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver
the change of peak pressure value	intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery	comparison peak pressure (cmH2O) before/after recruitment maneuver
the change of lung compliance value	intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery	comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver
the change of arterial blood gas analysis	intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery	comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver
The difference of atelectasis	at postoperative 30 minutes	atelectasis score by lung ultrasonography (score range 0\~36)

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of