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

Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07299968
Enrollment
170
Registered
2025-12-23
Start date
2025-12-31
Completion date
2026-02-28
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing Rate, Respiratory Rate

Keywords

respiratory rate, emergency department, Welch

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.

Detailed description

Design: prospective observational method comparison study

Interventions

None listed

Sponsors

Semmelweis University
CollaboratorOTHER
Dr. Rapszky Gabriella Anna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- all patients aged ≥18 years.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Agreement between respiratory rate values measured by the Welch Allyn Connex Spot Monitor and manual counts performed by trained observers (reference standard)During the emergency department visit (single measurement per participant).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.

Secondary

MeasureTime frameDescription
Agreement between respiratory rate values measured by trained observers and those recorded by triage nurses during triageDuring the emergency department visit (single measurement per participant).Respiratory rate measurements recorded by triage nurses during triage will be compared with manual 60-second counts performed by trained observers. Agreement between the two methods will be evaluated using the Intraclass Correlation Coefficient and Bland-Altman analysis to assess bias and limits of agreement.
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 arrhytmiasDuring the emergency department visit (single measurement per participant).Respiratory rate measurements recorded by triage nurses during triage will be compared with manual 60-second spot measurements performed by trained observers. Agreement between the two methods will be evaluated using the Intraclass Correlation Coefficient and Bland-Altman analysis to assess bias and limits of agreement.

Countries

Hungary

Contacts

Primary ContactBánk G Fenyves, MD, PhD
fenyves.bank@semmelweis.hu+3630016414
Backup ContactGabriella A Rapszky, MD
rapszky.gabriella.anna@semmelweis.hu+36305742899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026