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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01607723
Enrollment
13
Registered
2012-05-30
Start date
2012-05-31
Completion date
2014-03-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Intensive Care, Mechanical Ventilation, Ventilation Weaning

Keywords

Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)

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+.

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.

Interventions

OTHERNAVA ventilatory mode

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

OTHERPAV+ ventilatory mode

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Oxygenation in NAVA and in PAV+after one day of ventilation in NAVA and in PAV+

Secondary

MeasureTime frameDescription
Ventilatory comfortEvery 6 hours in the two ventilatory modesVentilatory 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 asynchroniesDuring 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.
Ventilatory parametersDuring 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).
Sleep patternDuring 24h of mechanical ventilation in NAVA and in PAV+

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026