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

Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Other: PEEP of 5 or 15 cm H2O

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69001
    • Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 1
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.	At day 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Hodane Yonis, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: respiratory mechanics; ARDS,; PEEP,; lung recruitment,; lung recruitability,; Chest-X-Ray,; lung imaging,; Pressure/Volume (PV) curve,; compliance,
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2013.818