NCT01607723

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+.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

Same day

First QC Date

April 18, 2012

Last Update Submit

December 2, 2014

Conditions

Critical IllnessMechanical VentilationIntensive CareVentilation Weaning

Keywords

Sleep patternMechanical ventilationweaningIntensive CareNAVA (Neurally Adjusted Ventilatory Assist)PAV+ (Proportional Assist Ventilation Plus)

Outcome Measures

Primary Outcomes (1)

  • Oxygenation in NAVA and in PAV+

    after one day of ventilation in NAVA and in PAV+

Secondary Outcomes (4)

  • Ventilatory comfort

    Every 6 hours in the two ventilatory modes

  • Patient-ventilator asynchronies

    During the 24h of mechanical ventilation in NAVA and in PAV+

  • Ventilatory parameters

    During the 24h of mechanical ventilation in NAVA and in PAV+

  • Sleep pattern

    During 24h of mechanical ventilation in NAVA and in PAV+

Study Arms (2)

NAVA ventilatory mode

OTHER
Other: NAVA ventilatory mode

PAV+ ventilatory mode

OTHER
Other: PAV+ ventilatory mode

Interventions

NAVA ventilatory modeOTHER

The two ventilatory modes will be studied during 24h in intubated patients in random order.

NAVA ventilatory mode
PAV+ ventilatory modeOTHER

The two ventilatory modes will be studied during 24h in intubated patients in random order.

PAV+ ventilatory mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Estimated remaining duration of mechanical ventilation for more than two days
  • patient alert and calm
  • Surrogate decision maker's consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

May 30, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2012

Study Completion

March 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

FR(1)