Back to results

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

Primary Purpose

Respiratory Distress Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ventilatory conditions and measures with scanner and EIT

About this trial

This is an interventional diagnostic trial for Respiratory Distress Syndrome focused on measuring positive expiratory pressure (PEP), Acute Respiratory Distress Syndrome (ARDS), electrical impedance tomography (EIT), tidal volume (TV), transpulmonary pressure (TPP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital de la Croix Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ventilatory conditions and measures with scanner and EIT

Arm Description

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

Outcomes

Primary Outcome Measures

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).

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)

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02896673

First Posted

August 31, 2016

Last Updated

November 14, 2018

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02896673

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 17, 2012 (Actual)

Primary Completion Date

January 21, 2015 (Actual)

Study Completion Date

January 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome

Keywords

positive expiratory pressure (PEP), Acute Respiratory Distress Syndrome (ARDS), electrical impedance tomography (EIT), tidal volume (TV), transpulmonary pressure (TPP)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ventilatory conditions and measures with scanner and EIT

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

ventilatory conditions and measures with scanner and EIT

Intervention Description

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

Primary Outcome Measure Information:

Title

mean values of optimal PEP obtained by EIT

Description

Time Frame

after 2 minutes of applying each ventilatory experience

Title

mean values of optimal TV obtained by EIT

Description

Time Frame

after 2 minutes of applying each ventilatory experience

Title

mean values of optimal PEP obtained by scan

Description

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).

Time Frame

after 4 minutes of applying each ventilatory experience

Title

mean values of optimal TV obtained by scan

Description

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).

Time Frame

after 4 minutes of applying each ventilatory experience

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 0.5. 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

Facility Information:

Facility Name

Hôpital de la Croix Rousse

City

Lyon

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs