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Clinical Trials/NCT02896673
NCT02896673
Completed
Not Applicable

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)

Hospices Civils de Lyon1 site in 1 country3 target enrollmentJuly 17, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
Hospices Civils de Lyon
Enrollment
3
Locations
1
Primary Endpoint
mean values of optimal TV obtained by scan
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2012
End Date
January 21, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

mean values of optimal TV obtained by scan

Time Frame: after 4 minutes of applying each ventilatory experience

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).

mean values of optimal PEP obtained by EIT

Time Frame: after 2 minutes of applying each ventilatory experience

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).

mean values of optimal PEP obtained by scan

Time Frame: after 4 minutes of applying each ventilatory experience

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).

mean values of optimal TV obtained by EIT

Time Frame: after 2 minutes of applying each ventilatory experience

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)

Study Sites (1)

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