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Completed

NCT Number: NCT03217305

Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation After Cardiac Surgery

The study compares two different ventilation modes, Pressure support ventilation vs. Neuronally Adjusted Ventilatory Assist, in postcardiac surgery patients. Of special interest is shunt and alveolar deadspace and ventral vs. dorsal ventilation.

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Key information

Conditions

Ventilator Lung

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

The aim of the study is to compare two different ventilation modes in complicated postcardiac surgery patients, who need ventilatory support during weaning phase, in the Cardiothoracic Intensive Care Unit. The two different ventilation modes are Neuronally Adjusted Ventilatory Assist (NAVA) and Pressure Support ventilation. NAVA ventilation mode have been introduced a couple of years ago as an alternative to pressure support. The advantage of NAVA mode compared to pressure support is a better synchrony between patient and ventilator in the inspired and expired phases. Maybe there are also physiological advantages of the NAVA mode, which we want to study in the present study.

All patients have three measurement periods. 1) Pressure support during 20 min, NAVA equilibration period of 30 min, followed by 2) NAVA ventilation for 20 min, pressure support equilibration period of 30 min and 3) pressure support for 20 min. Blood gases and cardiac output measurements is performed before and after each measurement period. Regional ventilation is measured by Electric Impedance Tomography (EIT).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Complicated Post Cardiac surgery patients in the ventilator weaning phase.
  • Patients requiring assisted ventilation
  • Respiratory and circulatory stable patients
  • Sedated patients, RASS -2 to -3

Exclusion criteria

  • Transplanted patients
  • Pleural effusion.

Treatment and study plan

NAVA

Device

Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

Primary outcomes

  1. Ventilation distribution

    Time frame: Through study completion, within approximately 18 months

    Redistribution of ventilation , dorsally vs. ventrally

  2. Alveolar dead space

    Time frame: Through study completion, within approximately 18 months

    Calculated from blood gases and end tidal pCO2,using standard formulae

  3. End expiratory lung impedance

    Time frame: Through study completion, within approximately 18 months

    Measured by Electric Impedance Tomography

  4. PaO2/FiO2

    Time frame: Through study completion, within approximately 18 months

    Arterial oxygenation

  5. Alveolar shunt

    Time frame: Through study completion, within approximately 18 months

    Calculated from mixed venous and arterial blood gases

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2017
Registry last updated
Apr 24, 2026

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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