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Clinical Trials/NCT03217305
NCT03217305
Completed
N/A

NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study

Sahlgrenska University Hospital2 sites in 1 country12 target enrollmentAugust 30, 2016
ConditionsVentilator Lung
InterventionsNAVA

Overview

Phase
N/A
Intervention
NAVA
Conditions
Ventilator Lung
Sponsor
Sahlgrenska University Hospital
Enrollment
12
Locations
2
Primary Endpoint
End expiratory lung impedance
Status
Completed
Last Updated
8 days ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 30, 2016
End Date
December 2, 2025
Last Updated
8 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Andreas Martinsson

MD

Göteborg University

Eligibility Criteria

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.

Arms & Interventions

NAVA vs Pressure Support

Control (pressure support) - NAVA - Control (Pressure Support) Intervention is NAVA

Intervention: NAVA

Outcomes

Primary Outcomes

End expiratory lung impedance

Time Frame: Through study completion, within approximately 18 months

Measured by Electric Impedance Tomography

Alveolar shunt

Time Frame: Through study completion, within approximately 18 months

Calculated from mixed venous and arterial blood gases

Ventilation distribution

Time Frame: Through study completion, within approximately 18 months

Redistribution of ventilation , dorsally vs. ventrally

Alveolar dead space

Time Frame: Through study completion, within approximately 18 months

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

PaO2/FiO2

Time Frame: Through study completion, within approximately 18 months

Arterial oxygenation

Study Sites (2)

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