Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Rapszky Gabriella Anna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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);
Trial population
The study will be conducted on patients admitted to the Emergency Department of Semmelweis University.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)
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.
Time frame
During the emergency department visit (single measurement per participant).Secondary outcomes
1
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.
Time frame
During the emergency department visit (single measurement per participant).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
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.
Time frame
During the emergency department visit (single measurement per participant).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Rapszky Gabriella Anna
Lead sponsor
Semmelweis University
Sponsor institution
Semmelweis University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: