Lung InjuryNCT03661502
Effect of Variable Volume Ventilation on Lung Compliance
A study testing VVV and PCV in people with Lung Injury, run by AZ Sint-Jan AV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Injury
- What is being tested?
- VVV and PCV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laparoscopic bariatric surgery requiring mechanical ventilation
Who cannot join
- lung disease requiring oxygen before anesthesia
- emergence procedure
- spontaneous or assisted ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Injury
- Being tested
- VVV, PCV
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VVVDevice
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
PCVDevice
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
| Study group | Role | What they receive |
|---|---|---|
| variable tidal volume ventilation (VVV) | Experimental | 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. Receives: Device: VVV |
| Pressure controlled ventilation (PCV) | Experimental | 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. Receives: Device: PCV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.
Secondary outcomes (1)
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
Measured: during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study startOct 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Marc Lanckneus, Study chair, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661502
- Sponsor's protocol ID
- JPM 2018 VVV
- Status last verified
- May 2019
- First submitted
- 4 Sep 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Variable Volume Ventilation on Lung Compliance During Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT03661502
- Acronym / sponsor ID
- JPM 2018 VVV
- Conditions
- Lung Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| variable tidal volume ventilation (VVV) | Experimental | Device: VVVthe 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. |
| Pressure controlled ventilation (PCV) | Experimental | Device: PCVthe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- laparoscopic bariatric surgery requiring mechanical ventilation
Key exclusion criteria (3 listed)
- lung disease requiring oxygen before anesthesia
- emergence procedure
- spontaneous or assisted ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VVVventilation 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 | Device | variable tidal volume ventilation (VVV) |
| PCVventilation 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 | Device | Pressure controlled ventilation (PCV) |
Primary outcome
Number of lung recruitments required to keep dynamic lung compliance above 40.
Time frame: during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.
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.
1 secondary outcome
Oxygen saturation at arrival of PACU without oxygen therapy.
Time frame: during stay in PACU being between 1 and 4 hours post operative of the same day. No outcome measurements are measured after 4 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lanckneus study chair
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VVV and PCV in people with Lung Injury, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier (003250452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lung recruitments required to keep dynamic lung compliance above 40. (time frame: during mechanical ventilation under general anesthesia between 1 and 3 hours. No outcome measurements are measured after 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.