"VARIABLE-PSV" Study
This study is not yet open for participant recruitment.
Verified April 2012 by University Hospital, Montpellier
Sponsor:
University Hospital, Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01580956
First received: April 18, 2012
Last updated: April 20, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Respiratory Failure Critical Illness Ventilation Weaning |
Other: VARIABLE-PSV ventilatory mode Other: STANDARD-PSV ventilatory mode |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Montpellier:
Primary Outcome Measures:
- Oxygenation in each ventilatory mode [ Time Frame: after 24h of mechanical ventilation in each mode ] [ Designated as safety issue: Yes ]We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
Secondary Outcome Measures:
- Ventilatory comfort [ Time Frame: during 24h in each mode ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
- Sleep quality [ Time Frame: after the 24 hours ] [ Designated as safety issue: Yes ]Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580956
Locations
| France | |
| Department of Anesthesiology & Critical Care, St Eloi University Hospital | Not yet recruiting |
| Montpellier, France, 34000 | |
| Contact: Samir JABER, MD, PhD + 33 4 67 33 72 71 s-jaber@chu-montpellier.fr | |
Sponsors and Collaborators
University Hospital, Montpellier
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01580956 History of Changes |
| Other Study ID Numbers: | UF 8897 |
| Study First Received: | April 18, 2012 |
| Last Updated: | April 20, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
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:
|
Critical Illness Respiratory Distress Syndrome, Adult Respiratory Insufficiency Disease Attributes |
Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders |
ClinicalTrials.gov processed this record on May 23, 2013