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

Not Applicable

Active, not recruiting

• Conditions: Ventilator Lung
• Interventions: Device: NAVA

• Registration Number: NCT03217305
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2016-08-30
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAVA vs Pressure Support	NAVA	Control (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA

Primary Outcome Measures

Name	Time	Method
End expiratory lung impedance	Through study completion, within approximately 18 months	Measured by Electric Impedance Tomography
PaO2/FiO2	Through study completion, within approximately 18 months	Arterial oxygenation
Alveolar shunt	Through study completion, within approximately 18 months	Calculated from mixed venous and arterial blood gases
Ventilation distribution	Through study completion, within approximately 18 months	Redistribution of ventilation , dorsally vs. ventrally
Alveolar dead space	Through study completion, within approximately 18 months	Calculated from blood gases and end tidal pCO2,using standard formulae

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden