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Not yet recruiting NCT07299968

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

— Observational Respiratory Rate Breathing Rate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Respiratory Rate, Breathing Rate. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • 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).]
Secondary outcome measures (2)
  • 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).]
  • 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).]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Hungary · 1 center
  • Department of Emergency Medicine, Semmelweis University — Budapest

Publications

  • Semler MW, Stover DG, Copland AP, Hong G, Johnson MJ, Kriss MS, Otepka H, Wang L, Christman BW, Rice TW. Flash mob research: a single-day, multicenter, resident-directed study of respiratory rate. Chest. 2013 Jun;143(6):1740-1744. doi: 10.1378/chest.12-1837. PMID 23197319
  • 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
  • Edmonds ZV, Mower WR, Lovato LM, Lomeli R. The reliability of vital sign measurements. Ann Emerg Med. 2002 Mar;39(3):233-7. doi: 10.1067/mem.2002.122017. PMID 11867974
  • 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
  • Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15. PMID 18522524
  • 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
  • Goldhill DR, McNarry AF, Mandersloot G, McGinley A. A physiologically-based early warning score for ward patients: the association between score and outcome. Anaesthesia. 2005 Jun;60(6):547-53. doi: 10.1111/j.1365-2044.2005.04186.x. PMID 15918825
  • 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

Identifiers

NCT: NCT07299968 · SOK-LEGZ25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗