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

NCT ID: NCT02081105

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-02-28

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

PEEP 5

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

Group Type: OTHER

PEEP of 5 or 15 cm H2O

Intervention Type: OTHER

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

Group Type: OTHER

PEEP of 5 or 15 cm H2O

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hodane Yonis, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Lyon, , France

Countries

France

Other Identifiers

2013.818

Identifier Type: -

Identifier Source: org_study_id