search
Back to results

Ventilator-driven Alveolar Recruitment Maneuver

Primary Purpose

Postoperative Atelectasis, Ventilator Lung, Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Alveolar recruitment maneuver
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Atelectasis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

positive end expiratory pressure group

tidal volume group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the change of Atelectasis volume
electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)

Secondary Outcome Measures

the change of lung compliance value
comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver
the change of arterial blood gas analysis
comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver
the change of driving pressure value
comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver
the change of peak pressure value
comparison peak pressure (cmH2O) before/after recruitment maneuver
The difference of atelectasis
atelectasis score by lung ultrasonography (score range 0~36)

Full Information

First Posted
February 2, 2020
Last Updated
November 8, 2020
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04258202
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atelectasis, Ventilator Lung, Atelectasis, Recruitment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
positive end expiratory pressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
tidal volume group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Alveolar recruitment maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of Atelectasis volume
Description
electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)
Time Frame
intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary Outcome Measure Information:
Title
the change of lung compliance value
Description
comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver
Time Frame
intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Title
the change of arterial blood gas analysis
Description
comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver
Time Frame
intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Title
the change of driving pressure value
Description
comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver
Time Frame
intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Title
the change of peak pressure value
Description
comparison peak pressure (cmH2O) before/after recruitment maneuver
Time Frame
intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Title
The difference of atelectasis
Description
atelectasis score by lung ultrasonography (score range 0~36)
Time Frame
at postoperative 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Ventilator-driven Alveolar Recruitment Maneuver

We'll reach out to this number within 24 hrs