Respiratory Distress SyndromeNCT02896673
Evaluation of the Diagnostic Performance of Electrical Impedance Tomography to Detect Situations at Risk of Lesions Induced by Conventional Mechanical Ventilation in ARDS
A study testing ventilatory conditions and measures with scanner and EIT in people with Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- ventilatory conditions and measures with scanner and EIT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2012to 21 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- ventilatory conditions and measures with scanner and EIT
- Keywords
- positive expiratory pressure (PEP), Acute Respiratory Distress Syndrome (ARDS), electrical impedance tomography (EIT), tidal volume (TV), transpulmonary pressure (TPP)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilatory conditions and measures with scanner and EITProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| ventilatory conditions and measures with scanner and EIT | Experimental | 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 Receives: Procedure: ventilatory conditions and measures with scanner and EIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: after 4 minutes of applying each ventilatory experience
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start17 Jul 2012
- Primary completion21 Jan 2015
- Study completion21 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896673
- Sponsor's protocol ID
- 2010-642
- Status last verified
- Nov 2018
- First submitted
- 31 Aug 2016
- Last updated
- 15 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02896673
- Acronym / sponsor ID
- 2010-642
- Conditions
- Respiratory Distress Syndrome
- Keywords
- positive expiratory pressure (PEP), Acute Respiratory Distress Syndrome (ARDS), electrical impedance tomography (EIT), tidal volume (TV), transpulmonary pressure (TPP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Jul 2012 (actual)
- Primary completion
- 21 Jan 2015 (actual)
- Study completion
- 21 Jan 2015 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilatory conditions and measures with scanner and EIT | Experimental | Procedure: ventilatory conditions and measures with scanner and EITThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- Excessively serious respiration precluding the modifications to ventilation planned in the protocol
- Contraindication for transport to the radiology department
- Without reliable monitoring during transport of the patient to the radiology department
- Intracranial hypertension
- Impossible to apply EIT electrodes on the thorax of the patient (burns, dressings, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilatory conditions and measures with scanner and EITDifferent 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 | Procedure or surgery | ventilatory conditions and measures with scanner and EIT |
Primary outcome
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 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)
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 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilatory conditions and measures with scanner and EIT in people with Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean values of optimal PEP obtained by EIT (time frame: after 2 minutes of applying each ventilatory experience). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.