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Ventilator-driven Alveolar Recruitment Maneuver

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04258202
Enrollment
64
Registered
2020-02-06
Start date
2020-03-02
Completion date
2020-10-08
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Atelectasis, Ventilator Lung, Atelectasis, Recruitment

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.

Interventions

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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the change of Atelectasis volumeintraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgeryelectrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)

Secondary

MeasureTime frameDescription
the change of lung compliance valueintraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgerycomparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver
the change of arterial blood gas analysisintraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgerycomparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver
the change of driving pressure valueintraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgerycomparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver
the change of peak pressure valueintraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgerycomparison peak pressure (cmH2O) before/after recruitment maneuver
The difference of atelectasisat postoperative 30 minutesatelectasis score by lung ultrasonography (score range 0\ 36)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026