Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 12:24 PM
Study NCT ID:
NCT03661502
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Variable Volume Ventilation on Lung Compliance
Sponsor:
AZ Sint-Jan AV
Organization:
Study Overview
Official Title:
Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: