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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01607723
First received: April 18, 2012
Last updated: August 28, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Critical Illness
Mechanical Ventilation
Intensive Care
Ventilation Weaning
Other: NAVA ventilatory mode
Other: PAV+ ventilatory mode
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Oxygenation in NAVA and in PAV+ [ Time Frame: after one day of ventilation in NAVA and in PAV+ ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ventilatory comfort [ Time Frame: Every 6 hours in the two ventilatory modes ] [ Designated as safety issue: Yes ]

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

  • Sleep pattern [ Time Frame: During 24h of mechanical ventilation in NAVA and in PAV+ ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: October 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607723

Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Hospital Recruiting
Montpellier, France, 34000
Contact: Samir JABER, MD PhD    + 33 4 67 33 72 71    s-jaber@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01607723     History of Changes
Other Study ID Numbers: UF 8916
Study First Received: April 18, 2012
Last Updated: August 28, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 24, 2014