Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 10:47 PM
Study NCT ID:
NCT07299968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of the Welch Allyn ConnexSpot Monitor in Measuring Respiratory Rate in the Emergency Department
Sponsor:
Dr. Rapszky Gabriella Anna
Organization:
Study Overview
Official Title:
Evaluation of the Welch Allyn Connex Spot Monitor in Measuring Respiratory Rate in the Emergency Department: a Prospective Observational Study Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: