Clinical Trial: NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-Invasive Ventilation With Neurally Adjusted Ventilatory Assist vs NIV Pressure Support or Pressure Control in Treatment of Patients With Acute Respiratory Insufficiency

Brief 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 Summary:

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.


Sponsor: Vejle Hospital

Current Primary Outcome:

  • Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45. [ Time Frame: 8 hours ]
  • Time for normalizing of Partial pressure of Oxygen (pO2) in arterial blood gases. Normal frame for pO2 7-14,4 (or to the usual level for the patient). [ Time Frame: 8 hours ]
  • Time for normalizing Carbon dioxide partial pressure (pCO2) in arterial blood gases. Normal frames pCO2 4,7-6,4 (or to the usual level for the patient). [ Time Frame: 8 hours ]
  • Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage). [ Time Frame: 8 hours ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient comfort [ Time Frame: 24 hours ]

There will be conducted a semi-interview on the subjects. They will be asked:

If they felt any difference in breathing between the two modes. If yes, what was the difference? Which method did you prefer? And why? Do you have any comments?



Original Secondary Outcome: Same as current

Information By: Vejle Hospital

Dates:
Date Received: October 14, 2015
Date Started: October 2015
Date Completion: May 2017
Last Updated: December 14, 2016
Last Verified: December 2016