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Effect of Variable Volume Ventilation on Lung Compliance

Primary Purpose

Lung Injury

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
VVV
PCV
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria:

  • lung disease requiring oxygen before anesthesia
  • emergence procedure
  • spontaneous or assisted ventilation

Sites / Locations

  • Azsintjan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

variable tidal volume ventilation (VVV)

Pressure controlled ventilation (PCV)

Arm Description

the intervention is using a ventilation mode with variable tidal volume. The average tidal volume is 6 ml/kg and respiratory rate adapted to reach an end tidalCO2 concentration between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.

the intervention is using ventilation mode with constant pressure and constant tidal volume. The tidal volume is 6 ml/kg and respiratory rate is adapted to reach end tidal CO2 concentrations between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.

Outcomes

Primary Outcome Measures

Number of lung recruitments required to keep dynamic lung compliance above 40.
Measuring dynamic lung compliance during mechanical ventilation. When it drops below 40 a lung recruitment is done with increase of PEEP to maximum 15 cmH2O.

Secondary Outcome Measures

Oxygen saturation at arrival of PACU without oxygen therapy.
oxygen saturation on arrival of PACU without giving oxygen I measured and compared between both groups

Full Information

First Posted
September 4, 2018
Last Updated
May 27, 2019
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT03661502
Brief Title
Effect of Variable Volume Ventilation on Lung Compliance
Official Title
Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV

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
Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.
Detailed Description
Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation (VVV) with a constant volume decelerating flow (PCV pressure controlled volume guarantee) ventilation. After anesthesia induction patients are VVV or PCV ventilated with a positive end expiratory pressure (PEEP) of 10 cm H2O. Average tidal volume is set at 6 ml/kg and end tidal CO2 is kept between 30 and 50 mmHg in both groups by adapting breaths per minute between 10 and 16. I/E ratio is set at 1/1 in VVV and at the standard ½ in PCV. Dynamic lung compliance is measured before and during pneumoperitoneum. If dynamic lung compliance is less than 40 or decreases below 40 a first lung recruitment (10 sec of 30 up to 40 cmH2O) is given till dyn compliance rises above 40. Dynamic lung compliance is further monitored and when value decreases again below 40, a new lung recruitment (LRM) is given and the PEEP is increased to 15 cm H2O after the second LRM. All patients get an opioid free general anesthesia with anti inflammatory agents and deep NMB with full reversal at end of surgery. The moment and number of LRM performed after induction of anesthesia with the averaged reached lung compliance is used to compare both ventilation methods. The oxygen saturation without oxygen at arrival of PACU and the need for oxygen when saturation drops below 95 % are compared between both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
variable tidal volume ventilation (VVV)
Arm Type
Experimental
Arm Description
the intervention is using a ventilation mode with variable tidal volume. The average tidal volume is 6 ml/kg and respiratory rate adapted to reach an end tidalCO2 concentration between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.
Arm Title
Pressure controlled ventilation (PCV)
Arm Type
Experimental
Arm Description
the intervention is using ventilation mode with constant pressure and constant tidal volume. The tidal volume is 6 ml/kg and respiratory rate is adapted to reach end tidal CO2 concentrations between 30 and 50 mmHg. Lung recruitment is given when dynamic lung compliance drops below 40. No drug is given. No other treatment or intervention is given.
Intervention Type
Device
Intervention Name(s)
VVV
Intervention Description
ventilation mode with variable tidal volume is chosen. the average tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg
Intervention Type
Device
Intervention Name(s)
PCV
Intervention Description
ventilation mode with constant tidal volume is chosen. the tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg
Primary Outcome Measure Information:
Title
Number of lung recruitments required to keep dynamic lung compliance above 40.
Description
Measuring dynamic lung compliance during mechanical ventilation. When it drops below 40 a lung recruitment is done with increase of PEEP to maximum 15 cmH2O.
Time Frame
during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.
Secondary Outcome Measure Information:
Title
Oxygen saturation at arrival of PACU without oxygen therapy.
Description
oxygen saturation on arrival of PACU without giving oxygen I measured and compared between both groups
Time Frame
during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: laparoscopic bariatric surgery requiring mechanical ventilation Exclusion Criteria: lung disease requiring oxygen before anesthesia emergence procedure spontaneous or assisted ventilation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Paul Mulier
Phone
003250452490
Email
jan.mulier@azsintjan.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Lanckneus
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Study Chair
Facility Information:
Facility Name
Azsintjan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Variable Volume Ventilation on Lung Compliance

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