Respiratory Mechanics Registry for ARDS Patients

July 24, 2017 updated by: Unity Health Toronto

Respiratory Mechanics in Acute Respiratory Distress Syndrome: A Quality Improvement-based Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Catholic University of the Sacred Heart
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ARDS
Other: Patients who have performed the ARDS pulmonary function test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Driving pressure (centimetre of water)
Time Frame: One hour
Epidemiology of physiological abnormalities in respiratory mechanics were be reported.
One hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Transpulmonary pressure (centimetre of water)
Time Frame: One hour
One hour
Respiratory compliance (millilitre / centimetre of water)
Time Frame: One hour
One hour
Lung compliance (millilitre / centimetre of water)
Time Frame: One hour
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Angers
Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB# 15-098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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