Functional Respiratory Imaging of Airways in ARDS

ARDS, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309085
• Other study ID #: EC 10/52/359
• Secondary ID: B300201010195
• Status: Completed
• Phase: N/A
• First received: October 3, 2017
• Last updated: October 12, 2017
• Start date: August 13, 2013
• Est. completion date: April 14, 2014

Study information

• Verified date: October 2017
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 14, 2014
• Est. primary completion date: April 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mechanically ventilated

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

Exclusion Criteria:

• pregnancy

• hemodynamic instability

• obesity (BMI >30)

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome, Adult

Intervention

Procedure:
• Repeated CT scan
CT scan of chest on different PEEP levels, 4 in total

Device:
• CT scan
CT scan

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Regional bronchial dilation	The difference in bronchial diameter from one PEEP level to the other	Through study completion, within 24 hours after inclusion
Primary	Regional alveolar recruitment	The difference in alveolar volume from one PEEP level to the other	Through study completion, within 24 hours after inclusion
Secondary	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