Respiratory Mechanics Registry for ARDS Patients

• ClinicalTrials.gov Identifier: NCT02623192
• Recruitment Status: Unknown
• First Posted: December 7, 2015
• Last Update Posted: July 26, 2017
• Sponsor: Unity Health Toronto
• Collaborators: Beijing Tiantan Hospital; University Hospital, Angers
• Information provided by (Responsible Party): Unity Health Toronto

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

Unity Health Toronto

Beijing Tiantan Hospital

University Hospital, Angers

Investigators

• Principal Investigator: Laurent Brochard, MD; Unity Health Toronto

More Information

Additional Information:

Publications:

Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guérin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen L, Chen GQ, Shore K, Shklar O, Martins C, Devenyi B, Lindsay P, McPhail H, Lanys A, Soliman I, Tuma M, Kim M, Porretta K, Greco P, Every H, Hayes C, Baker A, Friedrich JO, Brochard L. Implementing a bedside assessment of respiratory mechanics in patients with acute respiratory distress syndrome. Crit Care. 2017 Apr 4;21(1):84. doi: 10.1186/s13054-017-1671-8.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02623192
• Other Study ID Numbers: REB# 15-098
• First Posted: December 7, 2015
• Last Update Posted: July 26, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury