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Validation of Digital Chest-X-ray (CXR) to Assess Lung Recruitment in ARDS (RECRUTEX)

Primary Purpose

Acute Respiratory Distress Syndrome (ARDS)

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PEEP of 5 or 15 cm H2O
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome (ARDS) focused on measuring ARDS,, PEEP,, lung recruitment,, lung recruitability,, Chest-X-Ray,, lung imaging,, Pressure/Volume (PV) curve,, compliance,, respiratory mechanics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • intubation and mechanical ventilation in the ICU
  • Ramsay score 6 under sedation and analgesia
  • ICU respirator implemented with pressure-volume curve device
  • age equal to or greater than 18 years
  • ARDS defined from the Berlin criteria
  • absence of pneumothorax on the CXR before the study
  • Absence of pleural effusion greater than 500 ml estimated from ultrasonography.
  • no child-bearing woman
  • written inform consent signed by the next of kin

Exclusion Criteria:

  • Pneumothorax
  • Pleural effusion greater than 500 ml estimated from ultrasonography
  • Thoracic surgery in the last 3 months
  • Contra-indication to CXR
  • contra-indication to PEEP of 15 cm H2O
  • contra-indication to PEEP of 15 or PEEP 15 mandated
  • pressure-volume curve not feasible
  • refusal to participate
  • language barrier of the next of kin
  • child-bearing woman
  • person under legal protection

Sites / Locations

  • Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PEEP 5

PEEP 15

Arm Description

level of PEEP of 5 cm H2O randomly applied to the patient

level of PEEP of 15 cm H2O randomly applied to the patient

Outcomes

Primary Outcome Measures

Diagnostic performance of CXR to detect lung recruitability
1 CXR and 1 pressure-volume curve wil be performed at each PEEP for a given patient Determination of regions of interest in the posterior intercostal spaces of each lung in which density is measured to assess the total lung density at each PEEP. Measurement of Vrec between each PEEP level. One point per patient. Correlation of Vrec to change in density over all the patients and Receiver Operating Characteristic (ROC) curve of change in density to detect Vrec greater than 150 ml.

Secondary Outcome Measures

static compliance
Static compliance will be analysed at each PEEP. End-expiratory and end-inspiratory occlusion during the tidal breath to measure the effective static compliance at each PEEP. Change in static compliance between PEEP levels.
oxygenation
Oxygenation will be evaluated at each PEEP. Arterial blood gas measured at the end of each PEEP application for Oxygen Pressure in arterial blood (PaO2) and PaO2/ Inhaled Oxygen Fraction (FIO2) ratio.

Full Information

First Posted
February 27, 2014
Last Updated
January 10, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02081105
Brief Title
Validation of Digital Chest-X-ray (CXR) to Assess Lung Recruitment in ARDS
Acronym
RECRUTEX
Official Title
Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
The study stopped because it was difficult to recruit the 130 expected patients
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome (ARDS)
Keywords
ARDS,, PEEP,, lung recruitment,, lung recruitability,, Chest-X-Ray,, lung imaging,, Pressure/Volume (PV) curve,, compliance,, respiratory mechanics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP 5
Arm Type
Other
Arm Description
level of PEEP of 5 cm H2O randomly applied to the patient
Arm Title
PEEP 15
Arm Type
Other
Arm Description
level of PEEP of 15 cm H2O randomly applied to the patient
Intervention Type
Other
Intervention Name(s)
PEEP of 5 or 15 cm H2O
Intervention Description
PEEP of 5 or 15 cm H2O set at the respirator and applied to the patient for 10 minutes. Then, measurements are made at each PEEP in the following order: arterial blood gas, CXR, pressure-volume curve.
Primary Outcome Measure Information:
Title
Diagnostic performance of CXR to detect lung recruitability
Description
1 CXR and 1 pressure-volume curve wil be performed at each PEEP for a given patient Determination of regions of interest in the posterior intercostal spaces of each lung in which density is measured to assess the total lung density at each PEEP. Measurement of Vrec between each PEEP level. One point per patient. Correlation of Vrec to change in density over all the patients and Receiver Operating Characteristic (ROC) curve of change in density to detect Vrec greater than 150 ml.
Time Frame
At day 1
Secondary Outcome Measure Information:
Title
static compliance
Description
Static compliance will be analysed at each PEEP. End-expiratory and end-inspiratory occlusion during the tidal breath to measure the effective static compliance at each PEEP. Change in static compliance between PEEP levels.
Time Frame
At day 1
Title
oxygenation
Description
Oxygenation will be evaluated at each PEEP. Arterial blood gas measured at the end of each PEEP application for Oxygen Pressure in arterial blood (PaO2) and PaO2/ Inhaled Oxygen Fraction (FIO2) ratio.
Time Frame
At day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: intubation and mechanical ventilation in the ICU Ramsay score 6 under sedation and analgesia ICU respirator implemented with pressure-volume curve device age equal to or greater than 18 years ARDS defined from the Berlin criteria absence of pneumothorax on the CXR before the study Absence of pleural effusion greater than 500 ml estimated from ultrasonography. no child-bearing woman written inform consent signed by the next of kin Exclusion Criteria: Pneumothorax Pleural effusion greater than 500 ml estimated from ultrasonography Thoracic surgery in the last 3 months Contra-indication to CXR contra-indication to PEEP of 15 cm H2O contra-indication to PEEP of 15 or PEEP 15 mandated pressure-volume curve not feasible refusal to participate language barrier of the next of kin child-bearing woman person under legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hodane Yonis, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69001
Country
France

12. IPD Sharing Statement

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Validation of Digital Chest-X-ray (CXR) to Assess Lung Recruitment in ARDS

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