Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 83 for:    PEELING SKIN SYNDROME

NAVASET: Nava Level Titration Using Comfort Scales

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02133443
Recruitment Status : Unknown
Verified May 2014 by Nicolas TERZI, University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
Centre d'Investigation Clinique et Technologique 805
Information provided by (Responsible Party):
Nicolas TERZI, University Hospital, Caen

Brief Summary:
Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Device: PSV - pressure support ventilation Device: Neurally Adjusted Ventilatory Assist Not Applicable

Detailed Description:

Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.

We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
Study Start Date : April 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015


Arm Intervention/treatment
Active Comparator: Pressure Support Ventilation
Device: PSV - pressure support ventilation
Device: PSV - pressure support ventilation
Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Pressure support ventilator assistance to obtain a tidal volume of 6-8 ml/kg of ideal body weight.

Active Comparator: Neurally Adjusted Ventilatory Assist
Device: Partial ventilator support with partial ventilation mode (NAVA)
Device: Neurally Adjusted Ventilatory Assist
Partial ventilator support partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Stepwise implementation of the NAVA level (steps of 25% ), returning to the " optimal " level between each evaluation (PSV 100%, NAVA 100%, 75%, 50%, 125%, 150%).




Primary Outcome Measures :
  1. Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) [ Time Frame: 24hr ]
    To prove the feasibility of neurally adjusted ventilatory assist (NAVA) level titration according to the ventilatory comfort felt by the patient. The ventilatory comfort will be evaluated using the labeled visual analog scale (Banzett scale).


Secondary Outcome Measures :
  1. Efficiency [ Time Frame: 24hr ]
    The efficiency will be evaluated by using minute ventilation

  2. Efficiency [ Time Frame: 24hr ]
    The efficiency will be evaluated using arterial PCO2.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Hospitalized in intensive care unit for an acute respiratory failure
  • Intubated or tracheotomized and mechanically ventilated
  • RASS score: 0;-2
  • Weaning period

Exclusion Criteria:

  • Hemodynamic instability
  • Absence of consent
  • Contraindication of nasogastric catheter insertion

Information from the National Library of Medicine

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): NCT02133443


Locations
Layout table for location information
France
CHU de Caen Recruiting
Caen, France, 14000
Contact: Nicolas TERZI, MD-PhD    +33231064716    terzi-n@chu-caen.fr   
Principal Investigator: Nicolas TERZI, MD-PhD         
Sponsors and Collaborators
University Hospital, Caen
Centre d'Investigation Clinique et Technologique 805
Investigators
Layout table for investigator information
Principal Investigator: Nicolas TERZI, MD-PhD University Hospital, Caen
Principal Investigator: Frédéric Lofaso, MD-PhD University Hospital, Garches

Layout table for additonal information
Responsible Party: Nicolas TERZI, MD-PhD, University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02133443     History of Changes
Other Study ID Numbers: 2013-A01835-40
2013-A01835-40 ( Other Identifier: CPP Nord-Ouest III )
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014

Keywords provided by Nicolas TERZI, University Hospital, Caen:
Mechanical ventilation
Acute respiratory failure
Weaning
Pressure support ventilation
Neurally adjusted ventilatory assist

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases