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Surveillance Monitoring as an Alternative to Telemetry
NA trial testing Vital Sync IM & VPMP (Surveillance Monitoring) in Telemetry in 206 participants. Terminated before completion.
| Lead sponsor | Medtronic - MITG |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 206 |
| Start date | 3 April 2017 |
| Primary completion | 4 January 2018 |
| Estimated completion | 4 January 2018 |
| Sites | 1 location across United States |
Medtronic - MITG — full company profile →
18 and older, any sex, with Telemetry or Patient Monitoring. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.
| Group | Value | 95% CI |
|---|---|---|
| Telemetry Monitoring (TM) Arm | 79.9 | ± 73.0 |
Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.
| Group | Value | 95% CI |
|---|---|---|
| Telemetry Monitoring (TM) Arm | 143 |
Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.
| Group | Value | 95% CI |
|---|---|---|
| Telemetry Monitoring (TM) Arm | 4.4 | ± 4.9 |
CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.
| Group | Value | 95% CI |
|---|---|---|
| Telemetry Monitoring (TM) Arm | 14 |
Number of clinicians "very familiar" and "somewhat familiar" with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.
| Group | Value | 95% CI |
|---|---|---|
| Telemetry Monitoring (TM) Arm | 118 |
Time frame: The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing study enrollment. Completion is defined by when a subject is discharged from the hospital, completes 30 day (± 2 days) enrollment period, or if the subject is withdrawn from the study for any reason.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Telemetry Monitoring Arm | Surveillance Monitoring Arm |
|---|---|---|---|
| WORSENING ANEMIA | Blood and lymphatic system disorders | — | — |
| WORSENING HYPERTENSION | Vascular disorders | — | — |
| HYPOTENSION | Vascular disorders | — | — |
| NON STEMI | Cardiac disorders | — | — |
| NON SUSTAINED VENTRICULAR TACHYCARDIA | Cardiac disorders | — | — |
| WORSENING HYPERGLYCEMIA | Metabolism and nutrition disorders | — | — |
| WORSENING HYPERKALEMIA | Metabolism and nutrition disorders | — | — |
| ALTERED MENTAL STATUS | Psychiatric disorders | — | — |
| CARDIAC ARREST | Cardiac disorders | — | — |
| HYPERGLYCEMIA | Metabolism and nutrition disorders | — | — |
| HYPOGLYCEMIA | Metabolism and nutrition disorders | — | — |
| WORSENING ACUTE KIDNEY INJURY | Renal and urinary disorders | — | — |
| WORSENING GASTROINTESTINAL BLEED | Gastrointestinal disorders | — | — |
| WORSENING HYPOKALEMIA | Metabolism and nutrition disorders | — | — |
| WORSENING HYPOTENSION | Vascular disorders | — | — |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | — | — |
| AGITATED DELIRIUM | Psychiatric disorders | — | — |
| APHASIA | Nervous system disorders | — | — |
| ASPIRATION PNEUMONIA | Respiratory, thoracic and mediastinal disorders | — | — |
| EXPRESSIVE APHASIA | Nervous system disorders | — | — |
| FACIAL EDEMA (CONCERN FOR ALLERGIC REACTION VS. ATYPICAL ANGIOEDEMA) | General disorders | — | — |
| GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | — | — |
| GROSS HEMATURIA | Renal and urinary disorders | — | — |
| HEMORRHAGIC SHOCK (GI BLEED SOURCE) | Vascular disorders | — | — |
| HYPERCAPNIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Telemetry Monitoring Arm | Surveillance Monitoring Arm |
|---|---|---|---|
| CHEST PAIN | General disorders | — | — |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | — | — |
| AGITATION | Psychiatric disorders | — | — |
| HYPOTENSION | Vascular disorders | — | — |
| INCREASED ALTERED MENTAL STATUS | Psychiatric disorders | — | — |
| WORSENING LETHARGY | Nervous system disorders | — | — |
Most-reported serious reactions: WORSENING ANEMIA, WORSENING HYPERTENSION, HYPOTENSION, NON STEMI, NON SUSTAINED VENTRICULAR TACHYCARDIA, WORSENING HYPERGLYCEMIA, WORSENING HYPERKALEMIA, ALTERED MENTAL STATUS.
Data from ClinicalTrials.gov NCT03039738 adverse events section.
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.
No peer-reviewed publications indexed yet for this trial.
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