Acute Respiratory FailurePhase 3NCT01580956
"VARIABLE-PSV" Study
A Phase 3 study testing VARIABLE-PSV ventilatory mode and STANDARD-PSV ventilatory mode in people with Acute Respiratory Failure and Critical Illness, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Critical Illness, Ventilation Weaning
- What is being tested?
- VARIABLE-PSV ventilatory mode and STANDARD-PSV ventilatory mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Aug 2012
- Phase
- Phase 3
- 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
- ventilation planned for more than 48 h
- patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
- Age > or equal 18
- Surrogate decision maker's consent
Who cannot join
- Clinical instability for any reason.
- Life support withdrawal code
- Patient under tutelage
- Pregnancy
- No French health insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, 34000
About this study
Official title: Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.
Read the detailed description
Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.
- Being tested
- VARIABLE-PSV ventilatory mode, STANDARD-PSV ventilatory mode
- Keywords
- Acute respiratory failure, Critical illness, Mechanical ventilation, Ventilation weaning, Intensive Care Unit, Variable (NOISY) PSV, PSV
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIABLE-PSV ventilatory modeOther
The two ventilatory modes will be studied during 24h in intubated patients in random order.
STANDARD-PSV ventilatory modeOther
The two ventilatory modes will be studied during 24h in intubated patients in random order.
| Study group | Role | What they receive |
|---|---|---|
| VARIABLE-PSV ventilatory mode | Other | Not described Receives: Other: VARIABLE-PSV ventilatory mode |
| STANDARD-PSV ventilatory mode | Other | Not described Receives: Other: STANDARD-PSV ventilatory mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation in each ventilatory mode
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
Measured: after 24h of mechanical ventilation in each mode
Secondary outcomes (5)
Ventilatory comfort
Comfort zone is defined as previously reported in some papers as considered adequate ventilation : 6 < tidal volume < 10 ml/kg, ETCO2 < 55 mmHg and < 65 mmHg for COPD patients and 12 < Respiratory rate < 35 cycles/min.
Measured: during 24h in each mode
Feasibility
Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.
Measured: during the 24 hours
Patient/ventilator asynchronism
Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
Measured: during the 24 hours
Ventilatory effects
Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
Measured: during the 24 hours
Sleep quality
Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation
Measured: after the 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580956
- Sponsor's protocol ID
- UF 8897
- Status last verified
- Apr 2012
- First submitted
- 18 Apr 2012
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
- ClinicalTrials.gov ID
- NCT01580956
- Acronym / sponsor ID
- UF 8897
- Keywords
- Acute respiratory failure, Critical illness, Mechanical ventilation, Ventilation weaning, Intensive Care Unit, Variable (NOISY) PSV, PSV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Apr 2012 (estimated)
- 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.
Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.
Detailed description
Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VARIABLE-PSV ventilatory mode | Other | Other: VARIABLE-PSV ventilatory mode |
| STANDARD-PSV ventilatory mode | Other | Other: STANDARD-PSV ventilatory mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ventilation planned for more than 48 h
- patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
- Age > or equal 18
- Surrogate decision maker's consent
Key exclusion criteria (5 listed)
- Clinical instability for any reason.
- Life support withdrawal code
- Patient under tutelage
- Pregnancy
- No French health insurance
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 |
|---|---|---|
| VARIABLE-PSV ventilatory modeThe two ventilatory modes will be studied during 24h in intubated patients in random order. | Other | VARIABLE-PSV ventilatory mode |
| STANDARD-PSV ventilatory modeThe two ventilatory modes will be studied during 24h in intubated patients in random order. | Other | STANDARD-PSV ventilatory mode |
Primary outcome
Oxygenation in each ventilatory mode
Time frame: after 24h of mechanical ventilation in each mode
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
5 secondary outcomes
Ventilatory comfort
Time frame: during 24h in each mode
Feasibility
Time frame: during the 24 hours
Patient/ventilator asynchronism
Time frame: during the 24 hours
Ventilatory effects
Time frame: during the 24 hours
Sleep quality
Time frame: after the 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VARIABLE-PSV ventilatory mode and STANDARD-PSV ventilatory mode in people with Acute Respiratory Failure and Critical Illness, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 May 2013. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation in each ventilatory mode (time frame: after 24h of mechanical ventilation in each mode). 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 2013; AzTrials last refreshed its copy on 30 Oct 2026.