Functional Respiratory Imaging of Airways in ARDS

Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury

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.

Study Overview

• Status: Completed
• Conditions: ARDS, Human
• Intervention / Treatment: Procedure: Repeated CT scan; Device: CT scan

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, within 24 hours after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2013
• Primary Completion (Actual): April 14, 2014
• Study Completion (Actual): April 14, 2014

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: EC 10/52/359; B300201010195 (Registry Identifier: Belgian national registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No