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

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Recruiting

CT.gov ID

NCT03217305

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Lung	Device: NAVA	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Control-Intervention-ControlControl-Intervention-Control

Masking:

None (Open Label)

Masking Description:

The investigator works as physician at the Department of Intensive Care. The participants are patients.

Primary Purpose:

Treatment

Official Title:

NAVA vs Pressure Support After Cardiac Surgery, a Physiological Study

Actual Study Start Date :

Aug 30, 2016

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Goteborg		Sweden	41345

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

Principal Investigator: Anders Thoren, MD, PhD, University of Goteborg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andreas Martinsson, MD, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT03217305

Other Study ID Numbers:

AMartinssonthorax2

First Posted:

Jul 14, 2017

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andreas Martinsson, MD, Sahlgrenska University Hospital, Sweden

EIT. NAVA. Endexpiratory Lung Impedance.

Study Results

No Results Posted as of Dec 28, 2021