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

Ventilator Lung Clinical Trial

Official title:

NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217305
• Other study ID #: AMartinssonthorax2
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2016
• Est. completion date: April 30, 2025

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Anders Thoren, MD, PhD
• Phone: +46706963469
• Email: anders.thoren[@]medfak.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ventilator Lung

Intervention

Device:
• NAVA
Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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