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NCT Number: NCT07299968

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

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.

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Key information

Conditions

Respiratory Rate Breathing Rate Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Emergency Medicine, Semmelweis University

Budapest, 1082, Hungary

Location contact

Alexandra K Csapó

CONTACT

[email protected]

+36208250581

Gabriella Anna Rapszky, MD

SUB_INVESTIGATOR

About this study

Design: prospective observational method comparison study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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)

    Time frame: 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 outcomes

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

    Time frame: During 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.

  2. 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

    Time frame: During 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bánk G Fenyves, MD, PhD

CONTACT

[email protected]

+3630016414

Gabriella A Rapszky, MD

CONTACT

[email protected]

+36305742899

Sponsors and collaborators

Lead sponsor

Dr. Rapszky Gabriella Anna

Other

Collaborators

  • Semmelweis University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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