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Status unknownNCT02056093PAVANAVAUpdated Feb 5, 2014

Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

An interventional study of PSV mode and PAV mode in Acute Respiratory Failure, sponsored by Pierre and Marie Curie University. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Pierre and Marie Curie University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Acute Respiratory Failure

Keywords

  • NAVA - PAV- Breathing Variability - Asynchrony
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 16 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Pierre and Marie Curie University is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Intubated patients

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

    Device: PSV mode · Device: PAV mode · Device: NAVA

Interventions

  • DevicePSV mode

    Application of PSV in all patients

  • DevicePAV mode

    Application of PAV mode in all patients

  • DeviceNAVA
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What researchers measure

Primary outcomes

  1. Breathing pattern variability

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

    Time frame: February 2014

Secondary outcomes

  1. Patient-ventilator asynchrony

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

    Time frame: February, 2014

Other outcomes

  1. Electrical diaphragm activity Gas exchange

    measured by the NAVA probe

    Time frame: February 2014

07

Study locations

1 of 1 sites recruiting
  • Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
    Paris, Ile de France 75013, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25879592 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02056093
Lead sponsor
Pierre and Marie Curie University
Responsible party
Matthieu SCHMIDT (Dr, Pierre and Marie Curie University) — Principal investigator
First posted
Feb 5, 2014
Start date
Sep 2013
Primary completion
Feb 2014 (estimated)
Completion
Feb 2014 (estimated)
Last update
Feb 5, 2014

Study contacts

Matthieu SCHMIDT, MD
principal investigator · Association pour le Développement et l'Organisation de la Recherche en Pneumologie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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