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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02081105
First received: February 27, 2014
Last updated: March 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome (ARDS)
Other: PEEP of 5 or 15 cm H2O

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Diagnostic performance of CXR to detect lung recruitability [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 130
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PEEP 5
level of PEEP of 5 cm H2O randomly applied to the patient
Other: PEEP of 5 or 15 cm H2O
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.
PEEP 15
level of PEEP of 15 cm H2O randomly applied to the patient
Other: PEEP of 5 or 15 cm H2O
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081105

Contacts
Contact: Hodane YONIS, MD +33 4 26 10 92 64 yonis.hodane@chu-lyon.fr
Contact: Claude GUERIN, MD PhD +33 4 26 10 94 18 claude.guerin@chu-lyon.fr

Locations
France
Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon Recruiting
Lyon, France, 69001
Contact: Hodane YONIS, MD    +33 4 26 10 92 64    yonis.hodane@chu-lyon.fr   
Contact: Claude GUERIN, MD, PhD    +33 4 26 10 94 18    claude.guerin@chu-lyon.fr   
Principal Investigator: Hodane YONIS, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02081105     History of Changes
Other Study ID Numbers: 2013.818
Study First Received: February 27, 2014
Last Updated: March 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
ARDS,
PEEP,
lung recruitment,
lung recruitability,
Chest-X-Ray,
lung imaging,
Pressure/Volume (PV) curve,
compliance,
respiratory mechanics

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 20, 2014