NCT03309085

Brief Summary

This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 3, 2017

Last Update Submit

October 12, 2017

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (3)

  • Regional bronchial recruitment

    The difference in bronchial tree volume increase from one PEEP level to the other

    Through study completion, within 24 hours after inclusion

  • Regional bronchial dilation

    The difference in bronchial diameter from one PEEP level to the other

    Through study completion, within 24 hours after inclusion

  • Regional alveolar recruitment

    The difference in alveolar volume from one PEEP level to the other

    Through study completion, within 24 hours after inclusion

Secondary Outcomes (1)

  • Correlation between parenchymal recruitment and bronchial recruitment

    Through study completion, within 24 hours after inclusion

Study Arms (1)

Single arm

EXPERIMENTAL

Repeated CT scan

Procedure: Repeated CT scanDevice: CT scan

Interventions

Repeated CT scanPROCEDURE

CT scan of chest on different PEEP levels, 4 in total

Single arm
CT scanDEVICE

CT scan

Single arm

Eligibility Criteria

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

You may qualify if:

  • mechanically ventilated
  • moderate or severe ARDS, as defined by the Berlin criteria

You may not qualify if:

  • pregnancy
  • hemodynamic instability
  • obesity (BMI \>30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 13, 2017

Study Start

August 13, 2013

Primary Completion

April 14, 2014

Study Completion

April 14, 2014

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)