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

Completed

• Conditions: Acute Respiratory Insufficiency; Respiratory Insufficiency
• Interventions: Other: NIV-NAVA; Other: NIV-PS/PC

• Registration Number: NCT02592512
• Lead Sponsor: Vejle Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIV-NAVA	NIV-NAVA	4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC
NIV-NAVA	NIV-PS/PC	4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC
NIV-PS/PC	NIV-PS/PC	4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA
NIV-PS/PC	NIV-NAVA	4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA

Primary Outcome Measures

Name	Time	Method
Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).	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).	8 hours
Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.	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).	8 hours

Secondary Outcome Measures

Name	Time	Method
Patient comfort	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?

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Southern jetland, Denmark