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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05479929
Other study ID # 2020-195
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 30, 2020
Est. completion date October 2025

Study information

Verified date February 2023
Source CHRISTUS Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The investigators will assess inter-rater agreement between nurses & emergency physicians for assessment of work of breathing.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 39
Est. completion date October 2025
Est. primary completion date June 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Other:
Canadian Triage Assessment Scale (CTAS)
The CTAS incorporates work of breathing into a subjective measurement in its assessment of patients and triaged.

Locations

Country Name City State
United States CHRISTUS Spohn Hospital Corpus Christi Texas

Sponsors (1)

Lead Sponsor Collaborator
CHRISTUS Health

Country where clinical trial is conducted

United States, 

References & Publications (9)

Alquraini 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. — View Citation

Beveridge 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. — View Citation

Horeczko 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. — View Citation

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. — View Citation

Jimenez 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. — View Citation

Murray 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. — View Citation

Paniagua 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. — View Citation

Roussos C, Koutsoukou A. Respiratory failure. Eur Respir J Suppl. 2003 Nov;47:3s-14s. doi: 10.1183/09031936.03.00038503. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 months
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