Clinical trial NCT04258202: Ventilator-driven Alveolar Recruitment Maneuver
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Atelectasis
Ventilator Lung
Atelectasis
Recruitment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: the change of Atelectasis volume
timeFrame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary outcomes:
measure: the change of lung compliance value
timeFrame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
measure: the change of arterial blood gas analysis
timeFrame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
measure: the change of driving pressure value
timeFrame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
measure: the change of peak pressure value
timeFrame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
measure: The difference of atelectasis
timeFrame: at postoperative 30 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
References: