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Respiratory Mechanics Registry for ARDS Patients

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ClinicalTrials.gov Identifier: NCT02623192
Recruitment Status : Unknown
Verified July 2017 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : December 7, 2015
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
Beijing Tiantan Hospital
University Hospital, Angers
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
This registry was proposed to investigate the epidemiology of respiratory mechanics in patients with ARDS through collecting data from a QI project which was constituted with systematic assessments of respiratory mechanics and gas exchange.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Other: Patients who have performed the ARDS pulmonary function test

Detailed Description:
The amount of respiratory impairment in patients with Acute Respiratory Distress Syndrome (ARDS) is variable and applying the same ventilator regimen to every patient is questionable. In order to individualize ventilator management, monitoring respiratory mechanics may help to decide ventilator settings or set limits. A systematic assessment of respiratory mechanics and gas exchange response in patients who meet the criteria for ARDS has been initiated as a Quality Improvement (QI) project in the Department of Critical Care at St. Michael's Hospital. The QI project aims to facilitate the use of these parameters for ventilatory management. Measurements include: respiratory system, lung and chest wall mechanics (elastance and resistance), oxygenation response to positive end-expiratory pressure (PEEP), and estimate of alveolar recruitability using a simplified bedside maneuver[1]. Placement of an esophageal catheter is considered when the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤200 mmHg[2]. Audits are performed to see whether the measurements influence ventilatory management. Collecting these data into a registry will elicit helpful epidemiological information since the current epidemiological knowledge surrounding respiratory mechanics abnormalities in ARDS is limited. A registry with a large sample size may inform future recommendations. The investigators therefore propose to introduce the collected data from our QI program into an ARDS registry. Similar data obtained from other centers may also contribute to the registry in the future. The primary objective of the registry will be to investigate the epidemiology of abnormal respiratory mechanics in patients with ARDS.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: Respiratory Mechanics in Acute Respiratory Distress Syndrome: A Quality Improvement-based Registry
Study Start Date : August 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Group/Cohort Intervention/treatment
ARDS Other: Patients who have performed the ARDS pulmonary function test



Primary Outcome Measures :
  1. Driving pressure (centimetre of water) [ Time Frame: One hour ]
    Epidemiology of physiological abnormalities in respiratory mechanics were be reported.


Secondary Outcome Measures :
  1. Transpulmonary pressure (centimetre of water) [ Time Frame: One hour ]
  2. Respiratory compliance (millilitre / centimetre of water) [ Time Frame: One hour ]
  3. Lung compliance (millilitre / centimetre of water) [ Time Frame: One hour ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who have performed the ARDS pulmonary function test will be eligible for the registry. The clinical team discuss on a case-by-case basis to determine whether an ARDS patient is appropriate to received the ARDS pulmonary function test (systematic assessment of respiratory mechanics in the QI portion)
Criteria

Inclusion Criteria:

  • All patients admitted to the Medical-Surgical ICU, Trauma-Neuro ICU, and Cardiovascular ICU who meet the Berlin definition of ARDS and receive invasive ventilation.

Exclusion Criteria:

  • Severe hemodynamic instability: > 30% variation of mean arterial pressure and/or heart rate (HR) in the last 2 hours or the need for a high dose of vasopressors (higher than 0.5 µg/kg/min of norepinephrine);
  • Patients who present with a known esophageal problem, active upper gastrointestinal bleeding, or any other contraindication for the insertion of a gastric tube.

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): NCT02623192


Contacts
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Contact: Laurent Brochard, MD 416-864-5686 BrochardL@smh.ca

Locations
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Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Laurent Brochard       brochardl@smh.ca   
Italy
Catholic University of the Sacred Heart Recruiting
Rome, Lazio, Italy, 00168
Contact: Antonelli Massimo, MD    +39 06 30153226    Massimo.Antonelli@unicatt.it   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Beijing Tiantan Hospital
University Hospital, Angers
Investigators
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Principal Investigator: Laurent Brochard, MD St. Michael's Hospital, Toronto
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02623192    
Other Study ID Numbers: REB# 15-098
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury