Clinical trial NCT02592512: NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency
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. A Prospective, Randomised, Single Blinded, Crossover Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Acute Respiratory Insufficiency
Keywords: Hypoxia
hypercapnia
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU at Vejle Hospital, Denmark, 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 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.

Eligibility criteria: Inclusion Criteria:

* Patients admitted at the ICU with acute respiratory insufficiency and therefore have hypoxia(PaO2 \< 7 kPa on atmospheric air) og pH \< 7.35 with non-compensated hypercapnia (PaCO2 \> 6.0 kPa).
* Patients, which according to the departments guidelines are required to treatment with NIV

Exclusion Criteria:

* Patients under years of 18.
* Patients without the possibility to give informed consent.
* Patients with neuromuscular or neurological disease.
* Patients with a verified or suspected head trauma.
* Patients with a acknowledged hiatus hernia.
* Patients with an active or suspected active upper GI bleeding.
* Patients which have previously been in the study.
* Patients with a suspected or verified acute coronary syndrome.

Primary outcomes:
measure: Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.
timeFrame: 8 hours
measure: 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).
timeFrame: 8 hours
measure: 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).
timeFrame: 8 hours
measure: Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).
timeFrame: 8 hours
Secondary outcomes:
measure: Patient comfort
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Southern jetland
Study officials:
affiliation: Vejle Hospital
name: Alan Kimper-Karl, MD
role: STUDY_CHAIR
References: