- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02133443
NAVASET: Nava Level Titration Using Comfort Scales
Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- CHU de Caen
-
Contact:
- Nicolas TERZI, MD-PhD
- Phone Number: +33231064716
- Email: terzi-n@chu-caen.fr
-
Principal Investigator:
- Nicolas TERZI, MD-PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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)
|
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%).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
24hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficiency
Time Frame: 24hr
|
The efficiency will be evaluated by using minute ventilation
|
24hr
|
Efficiency
Time Frame: 24hr
|
The efficiency will be evaluated using arterial PCO2.
|
24hr
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolas TERZI, MD-PhD, University Hospital, Caen
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A01835-40 (OTHER: CPP Nord-Ouest III)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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