Effect of Variable Volume Ventilation on Lung Compliance

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

Randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.

Study Overview

• Status: Unknown
• Conditions: Lung Injury
• Intervention / Treatment: Device: VVV; Device: PCV

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Paul Mulier; Phone Number: 003250452490; Email: jan.mulier@azsintjan.be

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: variable tidal volume ventilation (VVV); 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.	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
Experimental: Pressure controlled ventilation (PCV); 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Study Chair: Marc Lanckneus, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury
• Other Study ID Numbers: JPM 2018 VVV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No