Evaluation of the Diagnostic Performance of Electrical Impedance Tomography to Detect Situations at Risk of Lesions Induced by Conventional Mechanical Ventilation in ARDS

Evaluation of the Diagnostic Performance of Electrical Impedance Tomography (EIT) to Detect Situations at Risk of Lesions Induced by Conventional Mechanical Ventilation in Acute Respiratory Distress Syndrome (ARDS)

Acute respiratory distress syndrome remains a serious condition, with a mortality rate of between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and pulmonary lesions induced by mechanical ventilation. It is therefore now established that the respirator settings influence patient prognosis. However, around 30% of patients with ARDS ventilated with these settings supposedly protective continue to present signs of pulmonary hyperinflation on tomodensitometry, suggesting an additional reduction in the tidal volume could be required in certain patients. Electrical impedance tomography (EIT) is a new imaging technique that gathers functional pulmonary information at bedside.

This technique also allows a regional analysis, allowing the complexity of the spatial distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a reliable method to detect at-risk situations of lesions induced by mechanical ventilation among patients with ARDS.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: ventilatory conditions and measures with scanner and EIT

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hôpital de la Croix Rousse

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:

• Aged ≥18 years
• Hospitalised in the medical resuscitation department of the Croix Rousse hospital, Lyon, Fr
• With ARDS according to the 1994 American-European Consensus Conference
• Duration of ARDS less than 96 hours
• With invasive mechanical ventilation
• With sedative and analgesic treatment for adaptation of the respirator with or without neuromuscular blocking agents
• Consent obtained from patient family
• Indication for thoracic scanner as judged by the physician in charge of the patient

Exclusion Criteria:

• Excessively serious respiration precluding the modifications to ventilation planned in the protocol

  • severe hypoxemia defined as sever by arterial blood pressure/fraction of inspired oxygen (PaO2/ FiO2) below 100 mm Hg in dorsal decubitus position
  • uncontrolled respiratory acidosis, defined by a pH below 7.25, despite an increase of respiratory frequency up to 35/min and a tidal volume up to 8 mL/kg of predicted weight
  • respiratory system plateau pressure higher than 30 cm H2O, with a tidal volume below or equal to 6 mL/kg of predicted weight.

• Contraindication for transport to the radiology department

  • uncontrolled hemodynamic instability defined by a mean arterial blood pressure below 65 mm Hg, despite use of antihypotensive agents
  • patient requiring continuous dialysis without possibility for disconnection for reason of uncontrolled metabolic acidosis (pH<7.20).

• Without reliable monitoring during transport of the patient to the radiology department

  • absence of invasive arterial pressure measurement
  • unreliable measurement of arterial saturation in oxygen (SpO2) defined by a perfusion index below 0.5.
• Intracranial hypertension
• Impossible to apply EIT electrodes on the thorax of the patient (burns, dressings, …)
• Undrained pneumothorax or bronchopleural fistula
• Scanner unavailable for the study (broken down, overloaded program, …)

• Contraindication esophageal balloon catheter

  • Known or suspected esophageal disease (tumor, esophageal varices, esophagitis, diverticulum, ...)
  • Latex allergy
• Patient previously included in the study
• Vulnerable persons (as defined in laws L1121-5 to L1121-7, L1121-8 and L1122-1-2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ventilatory conditions and measures with scanner and EIT; The patient is installed on the scanner bed, EIT electrodes are connected to the acquisition device of the EIT signal. Esophageal pressure signals, pressure and flow in the airways will be acquired continuously

Procedure: ventilatory conditions and measures with scanner and EIT; Different ventilatory conditions are studied and measures are acquired with scanner and EIT Time A: measure under basal conditions (TVbasal=6ml/kg of predicted weight), basal PEP, basal inspiratory time / total time = 30%) Time B: different PEP are applied for 4 minutes: 5, 10, 15, 20 cm of H2O conserving the basal TV Time C: different TV are applied for 4 minutes: 4, 7, 10 ml/kg of predicted weight conserving the basal PEP and the basal inspiratory time Time D: recruitment in continuous positive airway pressure at 45 cm of H2O is performed for 30 seconds Time E: return to adjustment period A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean values of optimal PEP obtained by EIT	Data acquisition will be carried out for 2 minutes and will start after 2 minutes of applying each ventilatory long time experience (A, B, C, E). mean values of optimal PEP will be compared between the 2 methods (scan and EIT).	after 2 minutes of applying each ventilatory experience
mean values of optimal TV obtained by EIT	Data acquisition will be carried out for 2 minutes and will start after 2 minutes of applying each ventilatory long time experience (A, B, C, E). mean values of optimal TV will be compared between the 2 methods (scan and EIT)	after 2 minutes of applying each ventilatory experience
mean values of optimal PEP obtained by scan	Data acquisition will start after 4 minutes of applying each ventilatory long time experience (A, B, C, D). mean values of optimal PEP will be compared between the 2 methods (scan and EIT).	after 4 minutes of applying each ventilatory experience
mean values of optimal TV obtained by scan	Data acquisition will start after 4 minutes of applying each ventilatory long time experience (A, B, C, D). mean values of optimal TV will be compared between the 2 methods (scan and EIT).	after 4 minutes of applying each ventilatory experience

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2012
• Primary Completion (Actual): January 21, 2015
• Study Completion (Actual): January 21, 2015

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: electrical impedance tomography (EIT); Acute Respiratory Distress Syndrome (ARDS); positive expiratory pressure (PEP); tidal volume (TV); transpulmonary pressure (TPP)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 2010-642