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ARDSBEARDSNCT03447288

Incidence of Dyssynchronies in Early ARDS

An observational study of ARDS and Acute Hypoxemic Respiratory Failure, run by Unity Health Toronto at 14 sites in 10 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients sedated under mechanical ventilation with acute hypoxemic respiratory failure with a PaO2/FiO2 equal or less than 200mmHg (Acute Respiratory Distress Syndrome, ARDS and non-ARDS) will be included in the study early in the course of the disease (first week of mechanical ventilation). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ARDS, Acute Hypoxemic Respiratory Failure
How many people
300 participants
Where
14 sitesin 10 countries
Study dates
15 Jan 2017to Aug 2022
How long will I take part?
60 Days
Phase
Observational
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

Study population: Patients with moderate to severe acute hypoxemic respiratory failure (ARDS and non-ARDS) under sedation and mechanical ventilation.

Who may be able to join

  • Moderate and severe ARDS and AHRF, according to the Berlin definition. The absence of the Chest X-Ray criterion (e.g. unilateral disease) or the presence of primary cardiac dysfunction will define AHRF.
  • Continuous intravenous sedation
  • Deep sedation: Richmond Agitation Sedation Scale (RASS) ≤ -3 or Riker Sedation-Agitation Scale (SAS) ≤ 3

Who cannot join

  • <18 years
  • Patients with a significant bronchopleural fistula
  • Pure COPD exacerbation
  • Patients on chronic home ventilation

Trial locations and contacts

14 sites in 10 countries.

Laurent Brochard, Dr. contact

416-864-6060 ext. 5686

BrochardL@smh.ca

Tài Pham, Dr. contact

647-643-29808

phamo@smh.ca

14 sites in 10 countries

Italy4 sites, 4 recruiting
  • University of Ferrara

    Ferrara

    Savino Spadaro, MD, savinospadaro@gmail.com

    Recruiting
  • Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia

    Foggia, 71122

    Gilda Cinnella, MD, +39 0881 73 23 07, gilda.cinnella@unifg.it

    Not yet recruiting
  • ASST Santi Paolo e Carlo

    Milan

    Davide Chiumello, Pr., 02 81844020, chiumello@libero.it

    Recruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan

    Tommaso Mauri, MD, tommymauri@gmail.com

    Recruiting

Other trials in Italy

Canada2 sites, 2 recruiting
  • St Michael's hospital

    Toronto, Ontario, M5B 1W8

    Tài Pham, Md, PhD, 647-643-2808, phamo@smh.ca

    Recruiting
  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

    Ewan C. Goligher, MD, FRCP(C), 416-586-8449, ewan.goligher@mail.utoronto.ca

    Not yet recruiting

Other trials in Canada

China1 site, 1 recruiting
  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100050

    Jian-Xin Zhou, MD, zhoujx.cn@icloud.com

    Not yet recruiting

Other trials in China

France1 site, 1 recruiting
  • Centre Hospitalier Universitaire - CHU Angers

    Angers, 49933

    Alain Mercat, MD, 33241353815, alain.mercat@univ-angers.fr

    Not yet recruiting

Other trials in France

Germany1 site, 1 recruiting
  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

    Tobias Besher, MD, Tobias.Becher@uksh.de

    Recruiting

Other trials in Germany

Greece1 site, 1 recruiting
  • University Hospital of Heraklion

    Heraklion, 711 10

    Dimitris Georgopoulos, MD, georgop@med.uoc.gr

    Eumorfia Kondili, MD, konde@med.uoc.gr

    Recruiting

Other trials in Greece

Netherlands1 site, 1 recruiting
  • VU University Medical Centre Amsterdam

    Amsterdam, 1007 MB

    Leo Heunks, Pr., +31 20 4443924, l.heunks@vumc.nl

    Heder de Vries, Dr., h.vries@vumc.nl

    Recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting
  • Vall d'Hebron University Hospital

    Barcelona

    Oriol Roca, MD, oroca@vhebron.net

    Recruiting

Other trials in Spain

Taiwan1 site, 1 recruiting
  • National Cheng-Kung University and Hospital

    Tainan, 704

    cwchen chen, MD, cwchen@mail.ncku.edu.tw

    Recruiting

Other trials in Taiwan

Thailand1 site, 1 recruiting
  • Siriraj Hospital

    Bangkok, 10700

    Nuttapol Rittayamai, MD, nuttapol.rit@mahidol.ac.th

    Recruiting

Other trials in Thailand

About this study

Official title: Incidence of Dyssynchronous Spontaneous Breathing Effort, Breath-stacking and Reverse Triggering in Early ARDS

Patients sedated under mechanical ventilation with acute hypoxemic respiratory failure with a PaO2/FiO2 equal or less than 200mmHg (Acute Respiratory Distress Syndrome, ARDS and non-ARDS) will be included in the study early in the course of the disease (first week of mechanical ventilation). At enrollment, data on the clinical condition of the patient will be recorded together with ventilation settings: ventilation mode, the fraction of inspired oxygen (FiO2), PEEP, tidal volume, set pressure, respiratory rate, time of the respiratory cycle, recent blood gas parameters.

Airway pressure, flow, and esophageal pressure (or alternatively electrical activity of the diaphragm, Eadi) will be recorded 3 times a day for 7 days:

Read more
  1. Period 1 (morning): duration 20-30 minutes
  2. Period 2 (afternoon): duration 20-30 minutes
  3. Period 3 (evening / night): duration 20-30 minutes

Registration will be ended at extubation, death or at eight days from the first recording.

Monitoring of vital parameters (hemodynamic and respiratory) will be continuous throughout the duration of the study, as per normal clinical practice. All drugs used during the day of the measurements will be recorded. The patient will then be followed until discharge from the ICU and after 60 days of discharge to evaluate mortality.

As an ancillary study, in a subgroup of patients continuous simplified measurement of respiratory recordings together with hourly clinical data on sedation and extended simplified polysomnography recordings will be performed within the first 7 days from inclusion.

The analysis of the recorded waveforms will be performed in a single center by a centralized system that will quantify dyssynchrony and its intensity, calculate pressure time product, collect clinical and physiological data and outcome, and investigate possible correlations.

Read the detailed description

Measurements

Physiological measurements Airway pressure, esophageal pressure, electrical activity of the diaphragm and flow

  1. Flow and airway pressure signal will be recorded from the ventilators by connecting the ventilator to a laptop computer if possible. Recording these data simultaneously with esophageal pressure or electrical activity of the diaphragm (see later in protocol for details) could be technically unfeasible. In this case, a flow sensor and an additional port for pressure measurement will be connected to the endotracheal tube proximal to the Y connector (without interfering with patient's breathing). Both, flow sensor and pressure port will be connected to differential pressure transducers respectively. Signals will be acquired with at least 100 Hz sampling.
  2. In centers used to perform esophageal pressure measurements, an esophageal catheter will be inserted as per usual clinical practice, checked for accuracy with an occlusion test, and connected to a 3 ways stopcock and a pressure transducer. The occlusion test will be recorded and performed before any new recordings. Any ventilator can be used if an esophageal pressure is used.
  3. If available, in centers used to record or monitor the electrical activity of the diaphragm, instead of an esophageal catheter, the electrical activity of the diaphragm will be provided by a catheter dedicated to the monitoring of the electrical activity of the diaphragm, or EaDi, on a Servo-I or Servo-U ventilator (Maquet©, Lund, Sweden). This catheter is formally designed to be used for a specific mode of ventilation called Neurally Adjusted Ventilatory Assist (NAVA) but here will be used for monitoring purposes only (NAVA catheter). In such cases a specific software (Servotracker, Maquet) may be used to record all signals from the ventilator.
  4. In case the patient has been enrolled but the esophageal catheter cannot be placed or is contraindicated, the recordings will be limited to airway pressure and flow. Each centre should have a minimum of 5 patients with esophageal catheter or electrical activity recording.
  5. As an ancillary study, in a subgroup of patients, simplified recordings will be obtained only flow and airway pressure signals will be performed continuously directly taken from the ventilator by connecting the ventilator to a laptop computer equipped with a special software for off line analysis (Better Care ©, Sabadell, Spain).
  6. Occlusion pressure (or pressure at 0.1 sec, P0.1) as an index of respiratory drive. In patients triggering the ventilator, the P0.1 will be analyzed from the tracings. The only condition to have reliable measurements is to use a pressure triggering, not a flow triggering.

As an ancillary study, in a subgroup of patients, a simplified extended polysomnography recording will be performed during the first 7 days after inclusion using a home polysomnography device (Prodigy, CerebraHealth ©, Canada) equipped with 2 frontal EEG a reference electrode to the mastoid, EMG, and electrooculogram.

Data collection

At the beginning of the recordings, ventilatory settings will be collected: ventilator brand, mode of ventilation and settings including: FiO2, PEEP, set and real tidal volume (or pressure), set and real respiratory rate, maximum inspiratory flow, inspiratory time, Glasgow coma scale and Richmond Agitation Sedation Scale (RASS) or Riker Sedation Agitation Scale (SAS). Any medications used at the day of the measurement and before will be collected especially neuromuscular blocking agents, sedatives (brands and doses), opiates and vasopressors including dose, duration of the treatment and date of last use. Investigators will also collect clinical characteristics of the patients (SAPS and SOFA at ICU admission and at the day of the recording, main ARDS or AHRF etiology and risk factors, age, gender, weight, height, days of mechanical ventilation, patient's position -supine vs prone-, kidney and liver function). Other comorbidities will be recorded, with special emphasis in the ones that could affect the incidence of the studied phenomenon, such as: COPD, lung transplant or any neuromuscular condition that could affect the respiratory drive or respiratory muscle function.

Patients will be followed up to get the total duration of mechanical ventilation, ICU length of stay, day of the first weaning attempt, day of tracheotomy if any, status at ICU discharge (alive or death) and at hospital discharge and at day 60.

Keywords
Dyssynchrony, Breath-stacking, Asynchrony, Reverse Triggering, Mechanical Ventilation, Sedation
Medical subject headings
Respiratory Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of dyssynchrony

    For each patients, the number of dyssynchrony (reverse triggering, breath stacking, short cycles) will be counted over the recorded period. An asynchrony index, (number of dyssynchrony divided by the total number of breaths) as well as the number of dyssynchrony per minute will be calculated globally and for each dyssynchrony type.

    Patients with ARDS will be compared to patients with AHRF. Patients with severe ARDS or severe AHRF (<120) will be compared to less severe patients.

    Measured: Within 1 Year

Secondary outcomes (9)
  1. Intensity of dyssynchrony

    Assessement of the frequency and magnitude of effort assessed by esophageal pressure or electrical activity of he diaphragm for each type of dyssynchrony

    Measured: Within 1 Year

  2. Correlation of clinical outcome with intensity of dyssynchrony

    Outcomes will be the duration of mechanical ventilation (in days); the number of ventilator-free days at day 28 (number of days alive without mechanical ventilation in 28 days; death equals 0 ventilator-free days); ICU survival and hospital survival. For each type of dyssynchrony, the outcomes will be correlated with the intensity of dyssynchrony.

    Intensity of dyssynchrony will be based on the dyssynchrony index above a minimal level of effort for each dyssynchrony.

    The outcomes above several thresholds of dyssynchrony index (10%, 30%, 50%) will be compared.

    Measured: Within 1 Year

  3. Impact of reverse triggering on breathing effort

    The breathing effort (pressure-time product) will be calculated and its value will be compared for breaths with and without reverse triggering.

    Measured: Within 1 Year

  4. Quantification of spontaneous breathing efforts associated with dyssynchronies.

    For each dyssynchrony found, the effort measured by the pressure-time product using esophageal pressure will be calculated. And the clinically relevant dyssynchronies will be determined based on a minimal amount of effort.

    Measured: Within 1 Year

  5. Association between pH and Dyssynchrony

    Arterial pH will be compared at different values of dyssynchrony index above a minimal level (10%, 30% and 50%).

    Measured: Within 1 Year

  6. Association between sedation and Dyssynchrony

    Level of sedation (assessed either Sedation Agitation Score "SAS" or the Richmond Agitation and Sedation Scale "RASS") by the will be compared at different values of dyssynchrony index above a minimal level (10%, 30% and 50%).

    Measured: Within 1 Year

  7. Association between sedatives and Dyssynchrony

    Values of dyssynchrony index above a minimal level will be compared between patients receiving primarily propofol versus benzodiazepines.

    Measured: Within 1 Year

  8. Clusters of dyssynchronies

    Timing of detection of dyssynchrony

    Measured: Within 1 Year

  9. Sleep depth measured with EEG

    As part of an ancillary exploratory study, various measures of brain activity, using EEG derived parameters including distribution of sleep depth using an automated scoring system named Odds Ratio Product (ORP) will be studied. ORP score ranges from 0 (corresponding to deep sleep) to 2.5 (corresponding to full wakefulness).

    Measured: Within 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start15 Jan 2017
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
60 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03447288
Sponsor's protocol ID
17-182
Acronym
BEARDS
Status last verified
Sep 2021
First submitted
5 Jul 2017
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: We plan to share physiologic tracings with no participant identification.

Publications

  • Bianchi I, Grassi A, Pham T, Telias I, Teggia Droghi M, Vieira F, Jonkman A, Brochard L, Bellani G. Reliability of plateau pressure during patient-triggered assisted ventilation. Analysis of a multicentre database. J Crit Care. 2022 Apr;68:96-103. doi: 10.1016/j.jcrc.2021.12.002. Epub 2021 Dec 21.

    PubMed 34952477
  • Pham T, Montanya J, Telias I, Piraino T, Magrans R, Coudroy R, Damiani LF, Mellado Artigas R, Madorno M, Blanch L, Brochard L; BEARDS study investigators. Automated detection and quantification of reverse triggering effort under mechanical ventilation. Crit Care. 2021 Feb 15;25(1):60. doi: 10.1186/s13054-020-03387-3.

    PubMed 33588912

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS and Acute Hypoxemic Respiratory Failure, run by Unity Health Toronto at 14 sites in 10 countries.

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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy, Canada, China, France, Germany and 5 more countries. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Laurent Brochard, Dr. (416-864-6060 ext. 5686, BrochardL@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of dyssynchrony (time frame: Within 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03447288, which also lists 2 linked publications.

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 30 Sep 2021.

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