Respiratory RateNCT07299968
Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department
An observational study of Respiratory Rate and Breathing Rate, run by Dr. Rapszky Gabriella Anna at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Rate, Breathing Rate
- How many people
- 170 participants
- Where
- 1 siteHungary
- Study dates
- Dec 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted on patients admitted to the Emergency Department of Semmelweis University.
Who may be able to join
- all patients aged ≥18 years.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Department of Emergency Medicine, Semmelweis University
Budapest, 1082
Alexandra K Csapó, +36208250581, csapo.alexandra.klaudia@semmelweis.hu
Gabriella Anna Rapszky, MD
About this study
Official title: Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol
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.
Read the detailed description
Design: prospective observational method comparison study
- Conditions
- Respiratory Rate, Breathing Rate
- Keywords
- respiratory rate, emergency department, Welch
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: During the emergency department visit (single measurement per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Rapszky Gabriella Anna
- Sponsor type
- University, hospital or other
- Collaborators
- Semmelweis University
- Responsible party
- Sponsor-investigator, Dr. Rapszky Gabriella Anna, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299968
- Sponsor's protocol ID
- SOK-LEGZ25
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23197319Loots 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.
PubMed 35944945Edmonds 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.
PubMed 11867974Badawy 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.
PubMed 28652259Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15.
PubMed 18522524Churpek 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.
PubMed 22584764Goldhill 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.
PubMed 15918825Mochizuki 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.
PubMed 29123857Goldhill 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.
PubMed 10403864
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol
- ClinicalTrials.gov ID
- NCT07299968
- Acronym / sponsor ID
- SOK-LEGZ25
- Conditions
- Respiratory Rate, Breathing Rate
- Keywords
- respiratory rate, emergency department, Welch
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Dr. Rapszky Gabriella AnnaUniversity, hospital or other
- Collaborators
- Semmelweis University
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on patients admitted to the Emergency Department of Semmelweis University.
Key inclusion criteria (1 listed)
- all patients aged ≥18 years.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 23197319Semler 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.
- Background: PubMed 35944945Loots 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.
- Background: PubMed 11867974Edmonds 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.
- Background: PubMed 28652259Badawy 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.
- Background: PubMed 18522524Leuvan CH, Mitchell I. Missed opportunities? An observational study of vital sign measurements. Crit Care Resusc. 2008 Jun;10(2):111-15.
- Background: PubMed 22584764Churpek 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.
- Background: PubMed 15918825Goldhill 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.
- Background: PubMed 29123857Mochizuki 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.
- Background: PubMed 10403864Goldhill 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.
- Product page for the Welch Allyn Connex Spot MonitorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Rate and Breathing Rate, run by Dr. Rapszky Gabriella Anna at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bánk G Fenyves, MD, PhD (+3630016414, fenyves.bank@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07299968, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.