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Functional Respiratory Imaging of Airways in ARDS

NCT ID: NCT03309085

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-13

Study Completion Date

2014-04-14

Brief Summary

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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

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Conditions

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ARDS, Human

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Single arm

Repeated CT scan

Group Type EXPERIMENTAL

Repeated CT scan

Intervention Type PROCEDURE

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

CT scan

Intervention Type DEVICE

CT scan

Interventions

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Repeated CT scan

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

Intervention Type PROCEDURE

CT scan

CT scan

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* hemodynamic instability
* obesity (BMI \>30)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Tom Schepens, MD

Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B300201010195

Identifier Type: REGISTRY

Identifier Source: secondary_id

EC 10/52/359

Identifier Type: -

Identifier Source: org_study_id