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

NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Lung
• Intervention / Treatment: Device: NAVA

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NAVA vs Pressure Support; Control (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA	Device: NAVA; Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Anders Thoren, MD, PhD, University of Goteborg

Publications and helpful links

General Publications

• Martinsson A, Lundholm C, Ricksten SE, Oras J, Magnusson JM, Wallinder A, Sellgren J, Thoren A. Neurally adjusted ventilatory assist vs pressure support ventilation: short-term effects on shunt and dead space after cardiac surgery. Sci Rep. 2025 Dec 21;15(1):44234. doi: 10.1038/s41598-025-33097-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: EIT. NAVA. Endexpiratory Lung Impedance.
• Other Study ID Numbers: AMartinssonthorax2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No