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Functional Respiratory Imaging of Airways in ARDS

Primary Purpose

ARDS, Human

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Repeated CT scan
CT scan
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Repeated CT scan

Outcomes

Primary Outcome Measures

Regional bronchial recruitment
The difference in bronchial tree volume increase from one PEEP level to the other
Regional bronchial dilation
The difference in bronchial diameter from one PEEP level to the other
Regional alveolar recruitment
The difference in alveolar volume from one PEEP level to the other

Secondary Outcome Measures

Correlation between parenchymal recruitment and bronchial recruitment
Correlation between parenchymal recruitment (in milliliter) and bronchial (in milliliter) recruitment for each type of ARDS (focal versus diffuse)

Full Information

First Posted
October 3, 2017
Last Updated
October 12, 2017
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03309085
Brief Title
Functional Respiratory Imaging of Airways in ARDS
Official Title
Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 13, 2013 (Actual)
Primary Completion Date
April 14, 2014 (Actual)
Study Completion Date
April 14, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
Repeated CT scan
Intervention Type
Procedure
Intervention Name(s)
Repeated CT scan
Intervention Description
CT scan of chest on different PEEP levels, 4 in total
Intervention Type
Device
Intervention Name(s)
CT scan
Intervention Description
CT scan
Primary Outcome Measure Information:
Title
Regional bronchial recruitment
Description
The difference in bronchial tree volume increase from one PEEP level to the other
Time Frame
Through study completion, within 24 hours after inclusion
Title
Regional bronchial dilation
Description
The difference in bronchial diameter from one PEEP level to the other
Time Frame
Through study completion, within 24 hours after inclusion
Title
Regional alveolar recruitment
Description
The difference in alveolar volume from one PEEP level to the other
Time Frame
Through study completion, within 24 hours after inclusion
Secondary Outcome Measure Information:
Title
Correlation between parenchymal recruitment and bronchial recruitment
Description
Correlation between parenchymal recruitment (in milliliter) and bronchial (in milliliter) recruitment for each type of ARDS (focal versus diffuse)
Time Frame
Through study completion, within 24 hours after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mechanically ventilated moderate or severe ARDS, as defined by the Berlin criteria Exclusion Criteria: pregnancy hemodynamic instability obesity (BMI >30)
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Functional Respiratory Imaging of Airways in ARDS

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