Effect of Variable Volume Ventilation on Lung Compliance

Lung Injury Clinical Trial

Official title:

Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03661502
• Other study ID #: JPM 2018 VVV
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Lung Injury

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.