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

NCT ID: NCT03217305

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-30

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilator Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Control-Intervention-Control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NAVA vs Pressure Support

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

Group Type OTHER

NAVA

Intervention Type DEVICE

Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NAVA

Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andreas Martinsson

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Thoren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Goteborg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AMartinssonthorax2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.