NCT03217305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2025

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

9.1 years

First QC Date

June 21, 2017

Last Update Submit

April 21, 2026

Conditions

Keywords

EIT. NAVA. Endexpiratory Lung Impedance.

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

NAVA vs Pressure Support

OTHER

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

Device: NAVA

Interventions

NAVADEVICE

Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode

NAVA vs Pressure Support

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Transplanted patients
  • Pleural effusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (1)

  • 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 Officials

  • Anders Thoren, MD, PhD

    University of Goteborg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The investigator works as physician at the Department of Intensive Care. The participants are patients.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Control-Intervention-Control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2017

First Posted

July 14, 2017

Study Start

August 30, 2016

Primary Completion

September 30, 2025

Study Completion

December 2, 2025

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations