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Functional Respiratory Imaging of Airways in ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date October 13, 2017
Actual Study Start Date  ICMJE August 13, 2013
Actual Primary Completion Date April 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Respiratory Imaging of Airways in ARDS
Official Title  ICMJE Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Condition  ICMJE ARDS, Human
Intervention  ICMJE
  • Procedure: Repeated CT scan
    CT scan of chest on different PEEP levels, 4 in total
  • Device: CT scan
    CT scan
Study Arms  ICMJE Experimental: Single arm
Repeated CT scan
Interventions:
  • Procedure: Repeated CT scan
  • Device: CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2017)
7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 14, 2014
Actual Primary Completion Date April 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • hemodynamic instability
  • obesity (BMI >30)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309085
Other Study ID Numbers  ICMJE EC 10/52/359
B300201010195 ( Registry Identifier: Belgian national registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tom Schepens, MD, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Antwerp
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP