- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05534516
A Study of Physiologic Changes in a Telemetry Unit
September 29, 2025 updated by: Antonio J. Forte, Mayo Clinic
Physiologic Changes Associated With Health Deterioration, Medications and Fluids Used in the Telemetry Unit
The purpose of this study is to determine the physiological changes associated with health deterioration, as well as different types, doses, and routes of administration of medications and fluids in acutely ill patients.
Study Overview
Status
Enrolling by invitation
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients (18-65 years) admitted to the telemetry unit at Mayo Clinic Florida's Hospital with acute illness followed from admission to discharge.
Description
Inclusion Criteria: Mayo Clinic patients who:
- Admitted to telemetry unit
- With acute illness
- Received any type of medication via any route of administration (oral, sublingual, intranasal, inhalational, intramuscular, intravenous, subcutaneous, transdermal)
- Received any amount of any type of intravenous fluids
- Cognitively and/or physically be able to sign consent
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Rate
Time Frame: Baseline, through telemetry unit stay (approximately 1-3 days)
|
Number of beats per minute
|
Baseline, through telemetry unit stay (approximately 1-3 days)
|
|
Change in Blood Pressure
Time Frame: Baseline, through telemetry unit stay (approximately 1-3 days)
|
Measured in millimeters of mercury (mmHg)
|
Baseline, through telemetry unit stay (approximately 1-3 days)
|
|
Change in Respiratory Rate
Time Frame: Baseline, through telemetry unit stay (approximately 1-3 days)
|
Number of breaths per minute
|
Baseline, through telemetry unit stay (approximately 1-3 days)
|
|
Change in Oxygen Saturation Levels
Time Frame: Baseline, through telemetry unit stay (approximately 1-3 days)
|
Measured by a pulse oximeter reading reported as a percentage
|
Baseline, through telemetry unit stay (approximately 1-3 days)
|
|
Change in ECG morphology
Time Frame: Baseline, through telemetry unit stay (approximately 1-3 days)
|
Changes in ECG waveform appearance measured from the digital ECG waveform interpretation
|
Baseline, through telemetry unit stay (approximately 1-3 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio Forte, MD, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
September 6, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 9, 2022
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 29, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 22-006064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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