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Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist (PAVANAVA)

Primary Purpose

Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PSV mode
PAV mode
NAVA
Sponsored by
Pierre and Marie Curie University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring NAVA - PAV- Breathing Variability - Asynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intubated patients.
  • Mechanical ventilation for a respiratory reason.
  • Expected duration of Mechanical ventilation > 48 hrs.
  • Spontaneous breathing.
  • Sedations stopped for more than 24 hours.

Exclusion Criteria:

  • - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
  • Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases.
  • Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
  • Severe hypoxemia defined as PaO2/FiO2 ratio <200.
  • Decision to withhold life-sustaining treatment.
  • Pregnant women.
  • Minors < 18 years.

Sites / Locations

  • Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie SalpetriereRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intubated patients

Arm Description

Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.

Outcomes

Primary Outcome Measures

Breathing pattern variability
The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)

Secondary Outcome Measures

Patient-ventilator asynchrony
Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)

Full Information

First Posted
December 18, 2013
Last Updated
February 4, 2014
Sponsor
Pierre and Marie Curie University
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1. Study Identification

Unique Protocol Identification Number
NCT02056093
Brief Title
Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Acronym
PAVANAVA
Official Title
Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pierre and Marie Curie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
NAVA - PAV- Breathing Variability - Asynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intubated patients
Arm Type
Experimental
Arm Description
Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.
Intervention Type
Device
Intervention Name(s)
PSV mode
Intervention Description
Application of PSV in all patients
Intervention Type
Device
Intervention Name(s)
PAV mode
Intervention Description
Application of PAV mode in all patients
Intervention Type
Device
Intervention Name(s)
NAVA
Primary Outcome Measure Information:
Title
Breathing pattern variability
Description
The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)
Time Frame
February 2014
Secondary Outcome Measure Information:
Title
Patient-ventilator asynchrony
Description
Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)
Time Frame
February, 2014
Other Pre-specified Outcome Measures:
Title
Electrical diaphragm activity Gas exchange
Description
measured by the NAVA probe
Time Frame
February 2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated patients. Mechanical ventilation for a respiratory reason. Expected duration of Mechanical ventilation > 48 hrs. Spontaneous breathing. Sedations stopped for more than 24 hours. Exclusion Criteria: - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction. Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases. Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs. Severe hypoxemia defined as PaO2/FiO2 ratio <200. Decision to withhold life-sustaining treatment. Pregnant women. Minors < 18 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu SCHMIDT, MD
Organizational Affiliation
Association pour le Développement et l'Organisation de la Recherche en Pneumologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu SCHMIDT, MD
Email
matthieuschmidt@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Matthieu Schmidt, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25879592
Citation
Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
Results Reference
derived

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Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

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