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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Acute Respiratory Insufficiency
• Intervention / Treatment: Other: NIV-NAVA; Other: NIV-PS/PC

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Denmark
  • Southern jetland
    • Vejle, Southern jetland, Denmark, 7100
      • Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the ICU at Vejle Hospital, Denmark, with acute respiratory insufficiency.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NIV-NAVA; 4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC	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.; Other: 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.
NIV-PS/PC; 4 hour NIV-PS/PC, followed by 4 hour NIV-NAVA	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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Alan Kimper-Karl, MD, Vejle Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Hypoxia; hypercapnia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: NIV-NAVA vs NIV-PS/PC