Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department

NCT07299968 | Not Yet Recruiting

• 1 other identifier: SOK-LEGZ25
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study will evaluate the accuracy of the Welch Allyn Connex Spot Monitor equipped with a Masimo SpO₂ finger sensor in measuring respiratory rate in the emergency department. Respiratory rate is a key predictor of patient deterioration, yet it is frequently measured inaccurately when assessed manually. In this study, respiratory rate values obtained by the monitor will be compared against manual counts performed by trained observers (physicians). An additional analysis will compare respiratory rates measured by trained observers with those recorded by triage nurses during triage. A subgroup analysis will also investigate whether cardiac arrhythmias influence measurement accuracy. The aim is to examine if respiratory rates measured by the Welch Allyn Connex Spot Monitor are comparable to those obtained by trained observers and triage nurses in the emergency department.

Conditions

Respiratory Rate; Breathing Rate

Keywords

respiratory rate; emergency department; Welch

Outcome Measures

Primary Outcomes (1)

• Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard)

  Respiratory rate will be measured simultaneously using the Welch Allyn Connex Spot Monitor and by trained observers performing manual counting over 60 seconds. Agreement between the two methods will be assessed using the Intraclass Correlation Coefficient and Bland-Altman analysis to evaluate bias and limits of agreement.

  During the emergency department visit (single measurement per participant).

Secondary Outcomes (2)

• Agreement between respiratory rate values measured by trained observers and those recorded by triage nurses during triage

  During the emergency department visit (single measurement per participant).

• Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers in patients with ECG-confirmed arrhytmias

  During the emergency department visit (single measurement per participant).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on patients admitted to the Emergency Department of Semmelweis University.

You may qualify if:

• \- all patients aged ≥18 years.

You may not qualify if:

• patients receiving invasive or non-invasive respiratory support;
• patients with disorders causing involuntary movements;
• skin or digit abnormalities preventing proper application of the pulse oximeter;
• clinically unstable patients on arrival (requiring immediate transfer to the resuscitation area);
• patients with a left ventricular assist device (LVAD).

Sponsors & Collaborators

• Dr. Rapszky Gabriella Anna: lead
• Semmelweis University: collaborator

Study Sites (1)

Department of Emergency Medicine, Semmelweis University

Budapest, 1082, Hungary

Location

Related Publications (9)

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  PMID: 23197319 BACKGROUND

• Loots FJ, Dekker I, Wang RC, van Zanten AR, Hopstaken RM, Verheij TJ, Giesen P, Smits M. The accuracy and feasibility of respiratory rate measurements in acutely ill adult patients by GPs: a mixed-methods study. BJGP Open. 2022 Dec 20;6(4):BJGPO.2022.0029. doi: 10.3399/BJGPO.2022.0029. Print 2022 Dec.

  PMID: 35944945 BACKGROUND

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  PMID: 11867974 BACKGROUND

• Badawy J, Nguyen OK, Clark C, Halm EA, Makam AN. Is everyone really breathing 20 times a minute? Assessing epidemiology and variation in recorded respiratory rate in hospitalised adults. BMJ Qual Saf. 2017 Oct;26(10):832-836. doi: 10.1136/bmjqs-2017-006671. Epub 2017 Jun 26.

  PMID: 28652259 BACKGROUND

• Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15.

  PMID: 18522524 BACKGROUND

• Churpek MM, Yuen TC, Park SY, Meltzer DO, Hall JB, Edelson DP. Derivation of a cardiac arrest prediction model using ward vital signs*. Crit Care Med. 2012 Jul;40(7):2102-8. doi: 10.1097/CCM.0b013e318250aa5a.

  PMID: 22584764 BACKGROUND

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  PMID: 15918825 BACKGROUND

• Mochizuki K, Shintani R, Mori K, Sato T, Sakaguchi O, Takeshige K, Nitta K, Imamura H. Importance of respiratory rate for the prediction of clinical deterioration after emergency department discharge: a single-center, case-control study. Acute Med Surg. 2016 Nov 10;4(2):172-178. doi: 10.1002/ams2.252. eCollection 2017 Apr.

  PMID: 29123857 BACKGROUND

• Goldhill DR, White SA, Sumner A. Physiological values and procedures in the 24 h before ICU admission from the ward. Anaesthesia. 1999 Jun;54(6):529-34. doi: 10.1046/j.1365-2044.1999.00837.x.

  PMID: 10403864 BACKGROUND

Related Links

• Product page for the Welch Allyn Connex Spot Monitor

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bánk G Fenyves, MD, PhD

CONTACT

+3630016414; fenyves.bank@semmelweis.hu

Gabriella A Rapszky, MD

CONTACT

+36305742899; rapszky.gabriella.anna@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: subinvestigator (PhD student, resident)

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-10

Locations

HU (1)