Shortness of BreathNCT05479929
Work of Breathing Assessment in Triage Scale
An observational study of Shortness of Breath and Respiratory Symptoms, run by CHRISTUS Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Shortness of Breath, Respiratory Symptoms, Cough
- What is being tested?
- Canadian Triage Assessment Scale (CTAS)
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study subjects include any adult patients who present to the emergency department at Christus Spohn Hospital - Shoreline
Who may be able to join
- 18 years of age of older
- Presenting to the emergency department with a chief complaint of any type of respiratory symptom.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CHRISTUS Spohn Hospital
Corpus Christi, Texas, 78405
About this study
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.
Read the 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.
- Being tested
- Canadian Triage Assessment Scale (CTAS)
- Keywords
- Emergency Room, Respiratory Assessment, Work of Breathing
- Medical subject headings
- Dyspnea, Signs and Symptoms, Respiratory, Cough, Hypoxia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canadian Triage Assessment Scale (CTAS)Other
The CTAS incorporates work of breathing into a subjective measurement in its assessment of patients and triaged.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Respiratory Symptoms | The Canadian Triage Assessment Scale (CTAS) will be assessed via patient survey form and electronic chart review. Receives: Other: Canadian Triage Assessment Scale (CTAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater agreement between nurses and emergency physicians for the respiratory component of the Canadian Assessment Scale (CTAS)
The CTAS is utilized to qualitatively define work of breathing as severe, moderate, or mild. Kappa will be calculated to assess inter-rater reliability
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start30 Oct 2020
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Shortness of BreathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Richman, MD, CHRISTUS Health
- Investigators
- Christopher Durand, DO, Principal investigator, CHRISTUS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479929
- Sponsor's protocol ID
- 2020-195
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Principal Investigator may want to pursue other opportunities with collaborators and sponsors.
Publications
Rui P, Kang K, Albert M. National Hospital Ambulatory Medical Care Survey: 2013 Emergency Department Summary Tables. Available from: http://www.cdc.gov/nchs/data/ahcd/nhamcs_emergency/2013_ed_web_tables.pdf.
Hutchinson A, Pickering A, Williams P, Bland JM, Johnson MJ. Breathlessness and presentation to the emergency department: a survey and clinical record review. BMC Pulm Med. 2017 Mar 20;17(1):53. doi: 10.1186/s12890-017-0396-4.
PubMed 28320369Murray M, Bullard M, Grafstein E; CTAS Natioanal Working Group; CEDIS National Working Group. Revisions to the Canadian Emergency Department Triage and Acuity Scale implementation guidelines. CJEM. 2004 Nov;6(6):421-7. No abstract available.
PubMed 17378961Horeczko T, Enriquez B, McGrath NE, Gausche-Hill M, Lewis RJ. The Pediatric Assessment Triangle: accuracy of its application by nurses in the triage of children. J Emerg Nurs. 2013 Mar;39(2):182-9. doi: 10.1016/j.jen.2011.12.020. Epub 2012 Jul 24.
PubMed 22831826Jimenez JG, Murray MJ, Beveridge R, Pons JP, Cortes EA, Garrigos JB, Ferre MB. Implementation of the Canadian Emergency Department Triage and Acuity Scale (CTAS) in the Principality of Andorra: Can triage parameters serve as emergency department quality indicators? CJEM. 2003 Sep;5(5):315-22.
PubMed 17466139Alquraini M, Awad E, Hijazi R. Reliability of Canadian Emergency Department Triage and Acuity Scale (CTAS) in Saudi Arabia. Int J Emerg Med. 2015 Dec;8(1):80. doi: 10.1186/s12245-015-0080-5. Epub 2015 Aug 7.
PubMed 26251308Paniagua N, Elosegi A, Duo I, Fernandez A, Mojica E, Martinez-Indart L, Mintegi S, Benito J. Initial Asthma Severity Assessment Tools as Predictors of Hospitalization. J Emerg Med. 2017 Jul;53(1):10-17. doi: 10.1016/j.jemermed.2017.03.021. Epub 2017 Apr 14.
PubMed 28416251Roussos C, Koutsoukou A. Respiratory failure. Eur Respir J Suppl. 2003 Nov;47:3s-14s. doi: 10.1183/09031936.03.00038503.
PubMed 14621112Beveridge R, Ducharme J, Janes L, Beaulieu S, Walter S. Reliability of the Canadian emergency department triage and acuity scale: interrater agreement. Ann Emerg Med. 1999 Aug;34(2):155-9. doi: 10.1016/s0196-0644(99)70223-4.
PubMed 10424915
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work of Breathing Assessment in Triage Scale
- ClinicalTrials.gov ID
- NCT05479929
- Acronym / sponsor ID
- 2020-195
- Keywords
- Emergency Room, Respiratory Assessment, Work of Breathing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Respiratory Symptoms | – | Other: Canadian Triage Assessment Scale (CTAS)The Canadian Triage Assessment Scale (CTAS) will be assessed via patient survey form and electronic chart review. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study subjects include any adult patients who present to the emergency department at Christus Spohn Hospital - Shoreline
Key inclusion criteria (2 listed)
- 18 years of age of older
- Presenting to the emergency department with a chief complaint of any type of respiratory symptom.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canadian Triage Assessment Scale (CTAS)The CTAS incorporates work of breathing into a subjective measurement in its assessment of patients and triaged. | Other | Patients with Respiratory Symptoms |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- BackgroundRui P, Kang K, Albert M. National Hospital Ambulatory Medical Care Survey: 2013 Emergency Department Summary Tables. Available from: http://www.cdc.gov/nchs/data/ahcd/nhamcs_emergency/2013_ed_web_tables.pdf.
- Background: PubMed 28320369Hutchinson A, Pickering A, Williams P, Bland JM, Johnson MJ. Breathlessness and presentation to the emergency department: a survey and clinical record review. BMC Pulm Med. 2017 Mar 20;17(1):53. doi: 10.1186/s12890-017-0396-4.
- Background: PubMed 17378961Murray M, Bullard M, Grafstein E; CTAS Natioanal Working Group; CEDIS National Working Group. Revisions to the Canadian Emergency Department Triage and Acuity Scale implementation guidelines. CJEM. 2004 Nov;6(6):421-7. No abstract available.
- Background: PubMed 22831826Horeczko T, Enriquez B, McGrath NE, Gausche-Hill M, Lewis RJ. The Pediatric Assessment Triangle: accuracy of its application by nurses in the triage of children. J Emerg Nurs. 2013 Mar;39(2):182-9. doi: 10.1016/j.jen.2011.12.020. Epub 2012 Jul 24.
- Background: PubMed 17466139Jimenez JG, Murray MJ, Beveridge R, Pons JP, Cortes EA, Garrigos JB, Ferre MB. Implementation of the Canadian Emergency Department Triage and Acuity Scale (CTAS) in the Principality of Andorra: Can triage parameters serve as emergency department quality indicators? CJEM. 2003 Sep;5(5):315-22.
- Background: PubMed 26251308Alquraini M, Awad E, Hijazi R. Reliability of Canadian Emergency Department Triage and Acuity Scale (CTAS) in Saudi Arabia. Int J Emerg Med. 2015 Dec;8(1):80. doi: 10.1186/s12245-015-0080-5. Epub 2015 Aug 7.
- Background: PubMed 28416251Paniagua N, Elosegi A, Duo I, Fernandez A, Mojica E, Martinez-Indart L, Mintegi S, Benito J. Initial Asthma Severity Assessment Tools as Predictors of Hospitalization. J Emerg Med. 2017 Jul;53(1):10-17. doi: 10.1016/j.jemermed.2017.03.021. Epub 2017 Apr 14.
- Background: PubMed 14621112Roussos C, Koutsoukou A. Respiratory failure. Eur Respir J Suppl. 2003 Nov;47:3s-14s. doi: 10.1183/09031936.03.00038503.
- Background: PubMed 10424915Beveridge R, Ducharme J, Janes L, Beaulieu S, Walter S. Reliability of the Canadian emergency department triage and acuity scale: interrater agreement. Ann Emerg Med. 1999 Aug;34(2):155-9. doi: 10.1016/s0196-0644(99)70223-4.
- Individual participant dataSharing planned: Yes. The Principal Investigator may want to pursue other opportunities with collaborators and sponsors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Durand, DO principal investigator
CHRISTUS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shortness of Breath and Respiratory Symptoms, run by CHRISTUS Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater agreement between nurses and emergency physicians for the respiratory component of the Canadian Assessment Scale (CTAS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479929, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.