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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607723
• Other study ID #: UF 8916
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: December 2, 2014
• Start date: May 2012
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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+.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care
• Mechanical Ventilation
• Ventilation Weaning

Intervention

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

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation in NAVA and in PAV+		after one day of ventilation in NAVA and in PAV+	Yes
Secondary	Ventilatory comfort	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.	Every 6 hours in the two ventilatory modes	Yes
Secondary	Patient-ventilator asynchronies	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.	During the 24h of mechanical ventilation in NAVA and in PAV+	Yes
Secondary	Ventilatory parameters	The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).	During the 24h of mechanical ventilation in NAVA and in PAV+	Yes
Secondary	Sleep pattern		During 24h of mechanical ventilation in NAVA and in PAV+	Yes