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Completed

NCT Number: NCT01607723

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

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+.

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Key information

Conditions

Critical Illness Disease Attributes Intensive Care Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Ventilation Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NAVA ventilatory mode

Other

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

PAV+ ventilatory mode

Other

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

Primary outcomes

  1. Oxygenation in NAVA and in PAV+

    Time frame: after one day of ventilation in NAVA and in PAV+

Secondary outcomes

  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+

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
May 30, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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