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Trial record 1 of 1 for:    Incidence of dyssynchronous spontaneous Breathing Effort, breath-stacking and reverse triggering in early ARDS
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Incidence of Dyssynchronies in Early ARDS (BEARDS)

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ClinicalTrials.gov Identifier: NCT03447288
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Brief 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). 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:

  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.


Condition or disease
ARDS Acute Hypoxemic Respiratory Failure

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Days
Official Title: Incidence of Dyssynchronous Spontaneous Breathing Effort, Breath-stacking and Reverse Triggering in Early ARDS
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022



Primary Outcome Measures :
  1. Prevalence of dyssynchrony [ Time Frame: Within 1 Year ]

    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.



Secondary Outcome Measures :
  1. Intensity of dyssynchrony [ Time Frame: Within 1 Year ]
    Assessement of the frequency and magnitude of effort assessed by esophageal pressure or electrical activity of he diaphragm for each type of dyssynchrony

  2. Correlation of clinical outcome with intensity of dyssynchrony [ Time Frame: Within 1 Year ]

    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.


  3. Impact of reverse triggering on breathing effort [ Time Frame: Within 1 Year ]
    The breathing effort (pressure-time product) will be calculated and its value will be compared for breaths with and without reverse triggering.

  4. Quantification of spontaneous breathing efforts associated with dyssynchronies. [ Time Frame: Within 1 Year ]
    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.

  5. Association between pH and Dyssynchrony [ Time Frame: Within 1 Year ]
    Arterial pH will be compared at different values of dyssynchrony index above a minimal level (10%, 30% and 50%).

  6. Association between sedation and Dyssynchrony [ Time Frame: Within 1 Year ]
    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%).

  7. Association between sedatives and Dyssynchrony [ Time Frame: Within 1 Year ]
    Values of dyssynchrony index above a minimal level will be compared between patients receiving primarily propofol versus benzodiazepines.

  8. Clusters of dyssynchronies [ Time Frame: Within 1 Year ]
    Timing of detection of dyssynchrony

  9. Sleep depth measured with EEG [ Time Frame: Within 1 Year ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe acute hypoxemic respiratory failure (ARDS and non-ARDS) under sedation and mechanical ventilation.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447288


Contacts
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Contact: Laurent Brochard, Dr. 416-864-6060 ext 5686 BrochardL@smh.ca
Contact: Tài Pham, Dr. 647-643-29808 phamo@smh.ca

Locations
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Canada, Ontario
St Michael's hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Tài Pham, Md, PhD    647-643-2808    phamo@smh.ca   
Toronto General Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Ewan C. Goligher, MD, FRCP(C)    416-586-8449    ewan.goligher@mail.utoronto.ca   
China
Beijing Tiantan Hospital, Capital Medical University Not yet recruiting
Beijing, China, 100050
Contact: Jian-Xin Zhou, MD       zhoujx.cn@icloud.com   
France
Centre Hospitalier Universitaire - CHU Angers Not yet recruiting
Angers, France, 49933
Contact: Alain Mercat, MD    33241353815    alain.mercat@univ-angers.fr   
Germany
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Tobias Besher, MD       Tobias.Becher@uksh.de   
Greece
University Hospital of Heraklion Recruiting
Heraklion, Greece, 711 10
Contact: Dimitris Georgopoulos, MD       georgop@med.uoc.gr   
Contact: Eumorfia Kondili, MD       konde@med.uoc.gr   
Italy
University of Ferrara Recruiting
Ferrara, Italy
Contact: Savino Spadaro, MD       savinospadaro@gmail.com   
Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia Not yet recruiting
Foggia, Italy, 71122
Contact: Gilda Cinnella, MD    +39 0881 73 23 07    gilda.cinnella@unifg.it   
ASST Santi Paolo e Carlo Recruiting
Milano, Italy
Contact: Davide Chiumello, Pr.    02 81844020    chiumello@libero.it   
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy
Contact: Tommaso Mauri, MD       tommymauri@gmail.com   
Netherlands
VU University Medical Centre Amsterdam Recruiting
Amsterdam, Netherlands, 1007 MB
Contact: Leo Heunks, Pr.    +31 20 4443924    l.heunks@vumc.nl   
Contact: Heder de Vries, Dr.       h.vries@vumc.nl   
Spain
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain
Contact: Oriol Roca, MD       oroca@vhebron.net   
Taiwan
National Cheng-Kung University and Hospital Recruiting
Tainan City, Taiwan, 704
Contact: cwchen chen, MD       cwchen@mail.ncku.edu.tw   
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Nuttapol Rittayamai, MD       nuttapol.rit@mahidol.ac.th   
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Laurent Brochard, Dr. Unity Health Toronto
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03447288    
Other Study ID Numbers: 17-182
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share physiologic tracings with no participant identification.
Keywords provided by Unity Health Toronto:
Dyssynchrony
Breath-stacking
Asynchrony
Reverse Triggering
Mechanical Ventilation
Sedation
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases