Back to resultsStudy Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.
Primary Purpose
Acute Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NAVA endotracheal tube
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Patient ventilated with endotracheal tube for more than 24 hours
- Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
- Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
- Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
Absence of administration of high-dose vasopressor therapy defined by:
- norepinephrine > 0.3 mcg / kg / min;
- dopamine > 10 mcg / kg / min;
- Estimated duration of mechanical ventilation > 48h00
Exclusion Criteria:
Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
- Recent gastrointestinal suture ;
- Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
- Therapeutic limitation or active treatment discontinuation;
- Pregnant women;
- Minors;
- Protected adults;
- Patient already included in the study;
Sites / Locations
- Hopital L'Archet 1
- Hopital PELLEGRIN
- Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
- Hôpital Dupuytren
- Hopital Saint-Eloi - CHU MONTPELLIER
- Hôpital de la Pitié Salpetrière
- Hopital Larrey- CHU D'ANGERS
- Hopital de la Cote de Nacre - CHU de CAEN
- Hopital d'Estaing
- Hopital de la CROIX ROUSSE
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
spontaneous NAVA mode
Inspiratory pressure support (IPS)
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
Secondary Outcome Measures
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode
Earnings on the "breathing comfort"
Earnings on sleep architecture
Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep.
Tolerance
Adverse events associated with the use of the device.
Incidence of ventilator-acquired pneumonia.
Duration of ICU stay.
Duration of hospital stay.
Mortality in the ICU.
Hospital mortality.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02018666
Brief Title
Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.
Official Title
ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinact
4. Oversight
5. Study Description
Brief Summary
This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spontaneous NAVA mode
Arm Type
Experimental
Arm Title
Inspiratory pressure support (IPS)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
NAVA endotracheal tube
Primary Outcome Measure Information:
Title
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
Description
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
Time Frame
Continuous recording during 48 hours following the intubation
Secondary Outcome Measure Information:
Title
Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index
Time Frame
Continuous recording during the first 48 hours
Title
Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).
Description
Feasibility of the initiation of mechanical ventilation in NAVA mode and feasibility of prolonged mechanical ventilation in NAVA mode
Time Frame
Continuous recording during the first 48 hours
Title
Earnings on the "breathing comfort"
Time Frame
Continuous recording during the first 48 hours
Title
Earnings on sleep architecture
Description
Total sleep time; Number of arousals per hour; Duration of stage IV sleep ; Duration of Rapid Eye Movement (REM) sleep.
Time Frame
Continuous recording during the first 48 hours
Title
Tolerance
Description
Adverse events associated with the use of the device.
Incidence of ventilator-acquired pneumonia.
Duration of ICU stay.
Duration of hospital stay.
Mortality in the ICU.
Hospital mortality.
Time Frame
Continuous for the duration of ICU stay, an expected maximum of 14 days
Other Pre-specified Outcome Measures:
Title
Number of implementation failure of the NAVA endotracheal tube.
Time Frame
For each patient, the success or failure of the endotracheal tube implementation will be evaluated, this for the entire duration of the study estimated to 18 months
Title
Number and duration of automatic switch into IPS mode
Time Frame
Continuous recording until extubation or D14 maximum
Title
Number of Permanent discontinuation of NAVA ventilation mode
Time Frame
Continuous recording during the first 48 hours
Title
Comfort of the device measured by a visual analog scale.
Description
Tolerance of the device
Time Frame
At the extubation or at D14 maximum
Title
Side effects associated with the use of the system
Description
Device movements Endotracheal tube obstruction Lesion of the oral or nasal mucosa
Time Frame
Continuous for the duration of ICU stay, an expected maximum of 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ventilated with endotracheal tube for more than 24 hours
Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
Absence of administration of high-dose vasopressor therapy defined by:
norepinephrine > 0.3 mcg / kg / min;
dopamine > 10 mcg / kg / min;
Estimated duration of mechanical ventilation > 48h00
Exclusion Criteria:
Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
Recent gastrointestinal suture ;
Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
Therapeutic limitation or active treatment discontinuation;
Pregnant women;
Minors;
Protected adults;
Patient already included in the study;
Facility Information:
Facility Name
Hopital L'Archet 1
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital PELLEGRIN
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Groupe Hospitalier Sud - Hôpital Haut-Leveque - Maison du Haut-Leveque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Dupuytren
City
Limoges
State/Province
Haute Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Saint-Eloi - CHU MONTPELLIER
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital de la Pitié Salpetrière
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Larrey- CHU D'ANGERS
City
Angers
State/Province
Maine Et Loire
ZIP/Postal Code
49933
Country
France
Facility Name
Hopital de la Cote de Nacre - CHU de CAEN
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Facility Name
Hopital d'Estaing
City
Clermont Ferrand
State/Province
Puy de Dome
ZIP/Postal Code
63100
Country
France
Facility Name
Hopital de la CROIX ROUSSE
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27686347
Citation
Demoule A, Clavel M, Rolland-Debord C, Perbet S, Terzi N, Kouatchet A, Wallet F, Roze H, Vargas F, Guerin C, Dellamonica J, Jaber S, Brochard L, Similowski T. Neurally adjusted ventilatory assist as an alternative to pressure support ventilation in adults: a French multicentre randomized trial. Intensive Care Med. 2016 Nov;42(11):1723-1732. doi: 10.1007/s00134-016-4447-8. Epub 2016 Sep 30.
Results Reference
derived
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Study Comparing Two Ventilation Modes NAVA (Neurally Adjusted Ventilatory Assist) Mode and Spontaneous Breathing With Inspiratory Pressure Support (IPS) Mode in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube.
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