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Completed

NCT Number: NCT03309085

Functional Respiratory Imaging of Airways in ARDS

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.

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Key information

Conditions

ARDS, Human Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Repeated CT scan

Procedure

CT scan of chest on different PEEP levels, 4 in total

CT Scan

Device

CT scan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 13, 2017
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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