"VARIABLE-PSV" Study - Full Text View

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:

MedlinePlus related topics: Respiratory Failure

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

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


Enrollment:	20
Study Start Date:	April 2012
Study Completion Date:	August 2012
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580956

Locations


France
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000

Sponsors and Collaborators

University Hospital, Montpellier

More Information


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:	May 28, 2013
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:


Respiratory Insufficiency Critical Illness Respiratory Distress Syndrome, Adult Respiration Disorders	Respiratory Tract Diseases Disease Attributes Pathologic Processes Lung Diseases

ClinicalTrials.gov processed this record on September 23, 2016