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
Sponsor study identifier
observational
30
1 country
1
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2015
Actual (reported)October 30, 2015
Actual (reported)April 2017
Actual (reported)April 2017
Actual (reported)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
Patient comfort
24 hours
4 hour NIV-NAVA, followed by 4 hour NIV-PS/PC
4 hour NIV-PS/PC, followed by 4 hour 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.
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.
Patients admitted to the ICU at Vejle Hospital, Denmark, with acute respiratory insufficiency.
Vejle Hospital
Vejle, Southern Jetland, 7100, Denmark
Alan Kimper-Karl, MD
Vejle Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2015
First Posted
October 30, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Helm CPAP Versus Mask CPAP After Major Abdominal Surgery
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Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)Last Updated
July 12, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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