Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.

NCT01928238 | Completed

• 1 other identifier: CHUBX 2011/27
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.

Conditions

Acute Respiratory Distress

Keywords

NIV; NAVA; noninvasive neurally adjusted ventilatory; noninvasive pressure support ventilation

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle effort

  The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.

  At inclusion (day 0)

Secondary Outcomes (3)

• patient ventilator synchrony

  At inclusion (Day 0)

• gas exchange

  At inclusion (Day 0)

• Patient comfort

  At inclusion (Day 0)

Study Arms (2)

Arm 1

EXPERIMENTAL

Patients will have two 20-minute noninvasive periods : Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV)

Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).; Device: Noninvasive pressure support ventilation (NPSV)

Arm 2

EXPERIMENTAL

Patients will have two 20-minute noninvasive periods : Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)

Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).; Device: Noninvasive pressure support ventilation (NPSV)

Interventions

Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). DEVICE

Arm 1; Arm 2

Noninvasive pressure support ventilation (NPSV) DEVICE

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients intubated for 48 h or more
• Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
• Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
• age older than 65 years
• Chronic obstructive pulmonary disease,
• heart failure as the cause for intubation
• An Acute Physiology and Chronic Health Evaluation (APACHE)-II score greater than 12 on the day of extubation.

You may not qualify if:

• Age younger than 18 years
• Head trauma or surgery
• Recent gastric or oesophageal surgery
• Active upper gastrointestinal bleeding
• Excessive amount of respiratory secretions
• Poor cooperation
• Decision to limit life-supporting treatments in the ICU
• Tracheostomy or other upper airway disorders
• Lack of collaboration
• Do not resuscitate order or any decision to limit therapeutic effort in the ICU.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frédéric VARGAS, MD-PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-01

Locations

FR (1)