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

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592512
• Other study ID #: NIV-NAVA vs NIV-PS/PC
• Status: Completed
• Phase: N/A
• First received: October 14, 2015
• Last updated: July 11, 2017
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle	Southern jetland

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.		8 hours
Primary	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
Primary	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
Primary	Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).		8 hours
Secondary	Patient comfort	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?	24 hours