NCT02592512

NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency

Non-Invasive Ventilation With Neurally Adjusted Ventilatory Assist vs NIV Pressure Support or Pressure Control in Treatment of Patients With Acute Respiratory Insufficiency. A Prospective, Randomised, Single Blinded, Crossover Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours. Afterwards they will be subjected to a semi-structured interview where they will be asked to compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for the patients.

Detailed description

Neurally Adjusted Ventilatory Assist (NAVA) is a ventilation mode where the diaphragm is controlling the amount of ventilatory assistance proportionally through a nasogastric tube containing electrodes which are sending the electrical activities of the diaphragm (Eadi) to the ventilator. Whereas Conventional ventilation modes like Pressure support or Pressure Control are dependent on the pressure drop or flow reversal to initiate assist delivered to the patient. This is last step of the signal chain leading to inhalation and is subject to disturbances such as intrinsic positive expiratory end pressure (PEEP), hyperinflation and leakage.

Conditions

• Respiratory Insufficiency
• Acute Respiratory Insufficiency

Interventions

Type	Name	Description
OTHER	NIV-NAVA	Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.
OTHER	NIV-PS/PC	Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-10-30
• Last updated: 2017-07-12

Locations

1 site across 1 country: Denmark