Effect of Variable Volume Ventilation on Lung Compliance

NCT ID: NCT03661502

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

VVV

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

PCV

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* laparoscopic bariatric surgery requiring mechanical ventilation

Exclusion Criteria

* lung disease requiring oxygen before anesthesia
* emergence procedure
* spontaneous or assisted ventilation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Mulier

head of dep anesthesia & intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marc Lanckneus

Role: STUDY_CHAIR

AZ Sint-Jan AV

Locations

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Azsintjan

Bruges, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Paul Mulier

Role: CONTACT

003250452490

Other Identifiers

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JPM 2018 VVV

Identifier Type: -

Identifier Source: org_study_id

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