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Completed

NCT Number: NCT02592512

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

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.

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Key information

Conditions

Respiratory Insufficiency Acute Respiratory Insufficiency Hypercapnia Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vejle Hospital

Vejle, Southern Jetland, 7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIV-NAVA

Other

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

Other

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.

Primary outcomes

  1. Time for normalizing of Power of Hydrogen (pH) in arterial blood gases. Normal pH frame 7.35-7.45.

    Time frame: 8 hours

  2. 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).

    Time frame: 8 hours

  3. 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).

    Time frame: 8 hours

  4. Electrical activity of the diaphragm (Eadi). Reduction in respiratory work assessed by Eadi (in percentage).

    Time frame: 8 hours

Secondary outcomes

  1. Patient comfort

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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