Respiratory Mechanics Registry for ARDS Patients

NCT ID: NCT02623192

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ARDS

Patients who have performed the ARDS pulmonary function test

Intervention Type OTHER

Interventions

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Patients who have performed the ARDS pulmonary function test

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Brochard, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Catholic University of the Sacred Heart

Rome, Lazio, Italy

Site Status RECRUITING

Countries

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Canada Italy

Central Contacts

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Laurent Brochard, MD

Role: CONTACT

416-864-5686

Facility Contacts

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Laurent Brochard

Role: primary

Antonelli Massimo, MD

Role: primary

+39 06 30153226

References

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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.

Reference Type BACKGROUND
PMID: 21866369 (View on PubMed)

Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin 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.

Reference Type BACKGROUND
PMID: 24467647 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28372575 (View on PubMed)

Other Identifiers

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REB# 15-098

Identifier Type: -

Identifier Source: org_study_id

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