Back to results"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes
Primary Purpose
Critical Illness, Mechanical Ventilation, Intensive Care
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
NAVA ventilatory mode
PAV+ ventilatory mode
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)
Eligibility Criteria
Inclusion Criteria:
- Estimated remaining duration of mechanical ventilation for more than two days
- patient alert and calm
- Surrogate decision maker's consent
Exclusion Criteria:
- Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
- Clinical instability for any reason
- Contraindications for continuing intensive care treatment
- Patient under tutelage
- Age < 18 years
- Pregnancy
- No French health insurance
Sites / Locations
- Department of Anesthesiology & Critical Care, St Eloi University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
NAVA ventilatory mode
PAV+ ventilatory mode
Arm Description
Outcomes
Primary Outcome Measures
Oxygenation in NAVA and in PAV+
Secondary Outcome Measures
Ventilatory comfort
Ventilatory comfort will be assessed by :
objective criteria expressed in time spent in each mode in the area called "comfort" (12 < Respiratory frequence < 28 c/min ; Current Volume > 300 mL and EtCO2 < 55 mmHg)
subjective criteria expressed by the self-assessment of the patient's comfort on a visual analogic scale.
Patient-ventilator asynchronies
The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respirator outputs.
Ventilatory parameters
The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).
Sleep pattern
Full Information
NCT ID
NCT01607723
First Posted
April 18, 2012
Last Updated
December 2, 2014
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01607723
Brief Title
"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes
Official Title
Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.
Detailed Description
Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation, Intensive Care, Ventilation Weaning
Keywords
Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAVA ventilatory mode
Arm Type
Other
Arm Title
PAV+ ventilatory mode
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
NAVA ventilatory mode
Intervention Description
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Intervention Type
Other
Intervention Name(s)
PAV+ ventilatory mode
Intervention Description
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Primary Outcome Measure Information:
Title
Oxygenation in NAVA and in PAV+
Time Frame
after one day of ventilation in NAVA and in PAV+
Secondary Outcome Measure Information:
Title
Ventilatory comfort
Description
Ventilatory comfort will be assessed by :
objective criteria expressed in time spent in each mode in the area called "comfort" (12 < Respiratory frequence < 28 c/min ; Current Volume > 300 mL and EtCO2 < 55 mmHg)
subjective criteria expressed by the self-assessment of the patient's comfort on a visual analogic scale.
Time Frame
Every 6 hours in the two ventilatory modes
Title
Patient-ventilator asynchronies
Description
The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respirator outputs.
Time Frame
During the 24h of mechanical ventilation in NAVA and in PAV+
Title
Ventilatory parameters
Description
The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).
Time Frame
During the 24h of mechanical ventilation in NAVA and in PAV+
Title
Sleep pattern
Time Frame
During 24h of mechanical ventilation in NAVA and in PAV+
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Estimated remaining duration of mechanical ventilation for more than two days
patient alert and calm
Surrogate decision maker's consent
Exclusion Criteria:
Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
Clinical instability for any reason
Contraindications for continuing intensive care treatment
Patient under tutelage
Age < 18 years
Pregnancy
No French health insurance
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, St Eloi University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Learn more about this trial
"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes
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