CClinicalTrials.gg
Status unknownNCT02623192Updated Jul 26, 2017

Respiratory Mechanics Registry for ARDS Patients

An observational study in Acute Respiratory Distress Syndrome, sponsored by Unity Health Toronto. Status unknown at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2017-07-26.

Sponsored by Unity Health Toronto · Observational

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
200
Sex
All
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Study 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.

Read the 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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Conditions studied

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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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)

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • ARDS

    Other: Patients who have performed the ARDS pulmonary function test

Interventions

  • OtherPatients who have performed the ARDS pulmonary function test
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What researchers measure

Primary outcomes

  1. Driving pressure (centimetre of water)

    Epidemiology of physiological abnormalities in respiratory mechanics were be reported.

    Time frame: One hour

Secondary outcomes

  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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Study locations

2 of 2 sites recruiting
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
    Recruiting
  • Catholic University of the Sacred Heart
    Rome, Lazio 00168, Italy
    Recruiting
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References and documents

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. PubMed 21866369 ↗
  • 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. PubMed 24467647 ↗
  • 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. PubMed 28372575 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02623192
Lead sponsor
Unity Health Toronto
Collaborators
Beijing Tiantan Hospital, University Hospital, Angers
Responsible party
Sponsor
First posted
Dec 7, 2015
Start date
Aug 2014
Primary completion
Aug 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Jul 26, 2017

Study contacts

Laurent Brochard, MD
Contact
BrochardL@smh.ca
416-864-5686
Laurent Brochard, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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