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

NCT ID: NCT07299968

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-02-28

Brief Summary

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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

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Design: prospective observational method comparison study

Conditions

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Respiratory Rate Breathing Rate

Keywords

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respiratory rate emergency department Welch

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role collaborator

Dr. Rapszky Gabriella Anna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rapszky Gabriella Anna

subinvestigator (PhD student, resident)

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Emergency Medicine, Semmelweis University

Budapest, , Hungary

Site Status

Countries

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Hungary

Central Contacts

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Bánk G Fenyves, MD, PhD

Role: CONTACT

Phone: +3630016414

Email: [email protected]

Gabriella A Rapszky, MD

Role: CONTACT

Phone: +36305742899

Email: [email protected]

Facility Contacts

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Alexandra K Csapó

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23197319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35944945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11867974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28652259 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18522524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22584764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15918825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29123857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10403864 (View on PubMed)

Related Links

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https://www.hillrom.com/en/products/connex-spot-monitor/

Product page for the Welch Allyn Connex Spot Monitor

Other Identifiers

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SOK-LEGZ25

Identifier Type: -

Identifier Source: org_study_id