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Functional Respiratory Imaging of Airways in ARDS

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ClinicalTrials.gov Identifier: NCT03309085
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Tom Schepens, MD, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
ARDS, Human Procedure: Repeated CT scan Device: CT scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
Actual Study Start Date : August 13, 2013
Actual Primary Completion Date : April 14, 2014
Actual Study Completion Date : April 14, 2014


Arm Intervention/treatment
Experimental: Single arm
Repeated CT scan
Procedure: Repeated CT scan
CT scan of chest on different PEEP levels, 4 in total

Device: CT scan
CT scan




Primary Outcome Measures :
  1. Regional bronchial recruitment [ Time Frame: Through study completion, within 24 hours after inclusion ]
    The difference in bronchial tree volume increase from one PEEP level to the other

  2. Regional bronchial dilation [ Time Frame: Through study completion, within 24 hours after inclusion ]
    The difference in bronchial diameter from one PEEP level to the other

  3. Regional alveolar recruitment [ Time Frame: Through study completion, within 24 hours after inclusion ]
    The difference in alveolar volume from one PEEP level to the other


Secondary Outcome Measures :
  1. Correlation between parenchymal recruitment and bronchial recruitment [ Time Frame: Through study completion, within 24 hours after inclusion ]
    Correlation between parenchymal recruitment (in milliliter) and bronchial (in milliliter) recruitment for each type of ARDS (focal versus diffuse)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309085


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
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Responsible Party: Tom Schepens, MD, Research fellow, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03309085    
Other Study ID Numbers: EC 10/52/359
B300201010195 ( Registry Identifier: Belgian national registry )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders