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
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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:
- Period 1 (morning): duration 20-30 minutes
- Period 2 (afternoon): duration 20-30 minutes
- 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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
- 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.
- 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
- 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.
- 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.
- 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.
- 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%).
- 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%).
- 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.
- Clusters of dyssynchronies [ Time Frame: Within 1 Year ]Timing of detection of dyssynchrony
- 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|
- 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
- <18 years
- Patients with a significant bronchopleural fistula
- Pure COPD exacerbation
- Patients on chronic home ventilation
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
|Contact: Laurent Brochard, Dr.||416-864-6060 ext 5686||BrochardL@smh.ca|
|Contact: Tài Pham, Dr.||email@example.com|
|St Michael's hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Contact: Tài Pham, Md, PhD 647-643-2808 firstname.lastname@example.org|
|Toronto General Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Ewan C. Goligher, MD, FRCP(C) 416-586-8449 email@example.com|
|Beijing Tiantan Hospital, Capital Medical University||Not yet recruiting|
|Beijing, China, 100050|
|Contact: Jian-Xin Zhou, MD firstname.lastname@example.org|
|Centre Hospitalier Universitaire - CHU Angers||Not yet recruiting|
|Angers, France, 49933|
|Contact: Alain Mercat, MD 33241353815 email@example.com|
|Kiel, Germany, 24105|
|Contact: Tobias Besher, MD Tobias.Becher@uksh.de|
|University Hospital of Heraklion||Recruiting|
|Heraklion, Greece, 711 10|
|Contact: Dimitris Georgopoulos, MD firstname.lastname@example.org|
|Contact: Eumorfia Kondili, MD email@example.com|
|University of Ferrara||Recruiting|
|Contact: Savino Spadaro, MD firstname.lastname@example.org|
|Azienda Ospedaliero - Universitaria OORR Ospedali Riuniti di Foggia||Not yet recruiting|
|Foggia, Italy, 71122|
|Contact: Gilda Cinnella, MD +39 0881 73 23 07 email@example.com|
|ASST Santi Paolo e Carlo||Recruiting|
|Contact: Davide Chiumello, Pr. 02 81844020 firstname.lastname@example.org|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Recruiting|
|Contact: Tommaso Mauri, MD email@example.com|
|VU University Medical Centre Amsterdam||Recruiting|
|Amsterdam, Netherlands, 1007 MB|
|Contact: Leo Heunks, Pr. +31 20 4443924 firstname.lastname@example.org|
|Contact: Heder de Vries, Dr. email@example.com|
|Vall d'Hebron University Hospital||Recruiting|
|Contact: Oriol Roca, MD firstname.lastname@example.org|
|National Cheng-Kung University and Hospital||Recruiting|
|Tainan City, Taiwan, 704|
|Contact: cwchen chen, MD email@example.com|
|Bangkok, Thailand, 10700|
|Contact: Nuttapol Rittayamai, MD firstname.lastname@example.org|
|Principal Investigator:||Laurent Brochard, Dr.||Unity Health Toronto|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Unity Health Toronto|
|Other Study ID Numbers:||
|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.|
Respiratory Tract Diseases