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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03661502
Other study ID # JPM 2018 VVV
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2019
Est. completion date December 2022

Study information

Verified date May 2019
Source AZ Sint-Jan AV
Contact Jan Paul Mulier
Phone 003250452490
Email jan.mulier@azsintjan.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria:

- lung disease requiring oxygen before anesthesia

- emergence procedure

- spontaneous or assisted ventilation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VVV
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
PCV
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

Locations

Country Name City State
Belgium Azsintjan Brugge

Sponsors (1)

Lead Sponsor Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.
Secondary 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 during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.
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