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"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

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ClinicalTrials.gov Identifier: NCT01607723
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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+.

Condition or disease Intervention/treatment Phase
Critical Illness Mechanical Ventilation Intensive Care Ventilation Weaning Other: NAVA ventilatory mode Other: PAV+ ventilatory mode Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
Study Start Date : May 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : March 2014

Arm Intervention/treatment
NAVA ventilatory mode Other: NAVA ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
PAV+ ventilatory mode Other: PAV+ ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.



Primary Outcome Measures :
  1. Oxygenation in NAVA and in PAV+ [ Time Frame: after one day of ventilation in NAVA and in PAV+ ]

Secondary Outcome Measures :
  1. Ventilatory comfort [ Time Frame: Every 6 hours in the two ventilatory modes ]

    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.

  2. Patient-ventilator asynchronies [ Time Frame: During the 24h of mechanical ventilation in NAVA and in PAV+ ]
    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.

  3. Ventilatory parameters [ Time Frame: During the 24h of mechanical ventilation in NAVA and in PAV+ ]
    The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).

  4. Sleep pattern [ Time Frame: During 24h of mechanical ventilation in NAVA and in PAV+ ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607723


Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01607723     History of Changes
Other Study ID Numbers: UF 8916
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Montpellier:
Sleep pattern
Mechanical ventilation
weaning
Intensive Care
NAVA (Neurally Adjusted Ventilatory Assist)
PAV+ (Proportional Assist Ventilation Plus)

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes