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

Vejle Hospital

Status: Completed

Conditions: Acute Respiratory Insufficiency; Respiratory Insufficiency

Treatments: Other: NIV-NAVA; Other: NIV-PS/PC

Study type: Observational

Funder types: Other

Identifiers

NCT02592512

NIV-NAVA vs NIV-PS/PC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

NIV-NAVA

Description:

4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC

Treatment:

Other: NIV-PS/PC

Other: NIV-NAVA

NIV-PS/PC

Description:

4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA

Treatment:

Other: NIV-PS/PC

Other: NIV-NAVA