Ventilator-driven Alveolar Recruitment Maneuver

Atelectasis Clinical Trial

Official title:

The Comparison of Ventilator-driven Alveolar Maneuver in Laparoscopic Surgery； Tidal Volume Controlled vs Positive End Expiratory Pressure Controlled Cycling Maneuvers； a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258202
• Other study ID #: SMC2019-11-117-003
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: October 8, 2020

Study information

• Verified date: January 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 8, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Postoperative Atelectasis
• Pulmonary Atelectasis
• Recruitment
• Ventilator Lung

Intervention

Other:
• Alveolar recruitment maneuver
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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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