Work of Breathing Assessment in Triage Scale

March 4, 2025 updated by: Peter Richman, MD, CHRISTUS Health
The proposed research study will be a prospective observational study designed to validate the Canadian Triage Assessment Scale (CTAS) in regard to work of breathing in patients in the emergency department. The investigators will assess inter-rater agreement between nurses & emergency physicians for assessment of work of breathing.

Study Overview

Detailed Description

Investigators will enroll a convenience sample of consenting patients who present to the emergency department with a chief complaint related to respiratory symptoms, including shortness of breath, cough, difficulty breathing, hypoxemia, or any other respiratory related complaint.

Following consent and in a blinded fashion, the nurse & emergency physician will be asked to evaluate the patient's work of breathing into three subjective categories: mild, moderate, or severe. The two evaluators will not be aware of the others evaluation of the patient. Evaluators will also be asked to predict the patients likely need for intervention & disposition.

Subsequently, investigators will perform a chart review to determine the patient's clinical interventions, outcomes, and dispositions, and evaluate the assessment of the patients work of breathing.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

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

Study Locations

    • Texas
      • Corpus Christi, Texas, United States, 78405
        • CHRISTUS Spohn Hospital

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study subjects include any adult patients who present to the emergency department at Christus Spohn Hospital - Shoreline

Description

Inclusion Criteria:

  • 18 years of age of older
  • Presenting to the emergency department with a chief complaint of any type of respiratory symptom.

Exclusion Criteria:

  • Under 18 years of age
  • Refusal to consent to study
  • Incarcerated patients
  • Pregnant patients
  • Unable to complete survey due to clinical instability, severe pain, or disorientation determined by a study physician.

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
Intervention / Treatment
Patients with Respiratory Symptoms
The Canadian Triage Assessment Scale (CTAS) will be assessed via patient survey form and electronic chart review.
The CTAS incorporates work of breathing into a subjective measurement in its assessment of patients and triaged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-rater agreement between nurses and emergency physicians for the respiratory component of the Canadian Assessment Scale (CTAS)
Time Frame: 24 months
The CTAS is utilized to qualitatively define work of breathing as severe, moderate, or mild. Kappa will be calculated to assess inter-rater reliability
24 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Christopher Durand, DO, CHRISTUS Health

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 (Actual)

October 30, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 21, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Principal Investigator may want to pursue other opportunities with collaborators and sponsors.

IPD Sharing Time Frame

24 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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