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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01607723
Other study ID # UF 8916
Secondary ID
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


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
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