"VARIABLE-PSV" Study
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ClinicalTrials.gov Identifier: NCT01580956 |
Recruitment Status :
Completed
First Posted : April 19, 2012
Last Update Posted : May 29, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Failure Critical Illness Ventilation Weaning | Other: VARIABLE-PSV ventilatory mode Other: STANDARD-PSV ventilatory mode | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
VARIABLE-PSV ventilatory mode |
Other: VARIABLE-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order. |
STANDARD-PSV ventilatory mode |
Other: STANDARD-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order. |
- 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.
- Ventilatory comfort [ Time Frame: during 24h in each mode ]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.
- Feasibility [ Time Frame: during the 24 hours ]Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.
- Patient/ventilator asynchronism [ Time Frame: during the 24 hours ]Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
- Ventilatory effects [ Time Frame: during the 24 hours ]Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
- Sleep quality [ Time Frame: after the 24 hours ]Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Clinical instability for any reason.
- Life support withdrawal code
- Patient under tutelage
- Pregnancy
- No French health insurance

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580956
France | |
Department of Anesthesiology & Critical Care, St Eloi University Hospital | |
Montpellier, France, 34000 |
Responsible Party: | University Hospital, Montpellier |
ClinicalTrials.gov Identifier: | NCT01580956 History of Changes |
Other Study ID Numbers: |
UF 8897 |
First Posted: | April 19, 2012 Key Record Dates |
Last Update Posted: | May 29, 2013 |
Last Verified: | April 2012 |
Keywords provided by University Hospital, Montpellier:
Acute respiratory failure Critical illness Mechanical ventilation Ventilation weaning |
Intensive Care Unit Variable (NOISY) PSV PSV |
Additional relevant MeSH terms:
Respiratory Insufficiency Critical Illness Respiratory Distress Syndrome, Adult Respiration Disorders |
Respiratory Tract Diseases Disease Attributes Pathologic Processes Lung Diseases |