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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Bispebjerg Hospital | OTHER |
| Technical University of Denmark |
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The primary aim of the current study is to assess the effect of continuous wireless vital sign monitoring with generation of real-time alerts, compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards after major surgery.
We hypothesize that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No alarms | No Intervention | Patients will be connected to monitoring equipment, registering vital sign data, but data will be blinded to clinical staff. | |
| Active alarms | Active Comparator | Patients will be connected to monitoring equipment, registering data, and data will be available to clinical staff, including alarms for vital sign deterioration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Alarms | Device | Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative duration | Cumulative duration of one or more deviations in vital signs. List of vital signs, and normal limits detailed in protocol. | During monitoring, for a maximum of up to 5 postoperative days or until discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of sustained deviation alerts | Frequency of each of the sustained deviations in vital signs. List of vital signs, and normal limits detailed in the protocol. | During monitoring, for a maximum of up to 5 postoperative days or until discharge. |
| Any adverse event |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay | 30 postoperative days and 6 months |
| Patient related post-admission healthcare expenses | Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Mølgaard, MD | Rigshospitalet, Denmark | Principal Investigator |
| Eske K Aasvang, MD, DMSc | Rigshospitalet, Denmark | Study Chair |
| Christian S Meyhoff, MD, PhD | Bispebjerg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Copenhagen NV | Copenhagen | 2400 | Denmark | ||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41941065 | Derived | Larsen AT, Sopina L, Molgaard J, Aasvang EK, Meyhoff CS, Kjellberg J, Kristensen SR. Impact of postoperative in-hospital continuous vital sign monitoring on healthcare costs, resource utilization and labor market outcomes. Eur J Health Econ. 2026 Apr 6. doi: 10.1007/s10198-026-01919-2. Online ahead of print. | |
| 40591492 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2022 | Nov 21, 2022 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
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Any adverse event. Criteria for each defined in protocol. Results will be compared between the case and control arm, on when it a diagnosis is made. Based on information in patient electronic medical file. |
| 7 days and 30 days after start of monitoring |
| Any serious adverse event | Any serious adverse event. Criteria for each defined in protocol. Serious Adverse Events will be determined using the criteria as defined in ICH-GCP terms. Results will be compared between the case and control arm, on when it a diagnosis is made. Based on information in patient electronic medical file. | 7 days and 30 days after start of monitoring |
| 2 years |
| Staff response time (intervention group only) | Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day | During monitoring, for a maximum of up to 5 postoperative days or until discharge, whichever comes first |
| Copenhagen |
| 2100 |
| Denmark |
| Molgaard J, Gronbaek KK, Rasmussen SS, Eiberg JP, Jorgensen LN, Achiam MP, Rohrsted M, Singh UM, Hoang TH, Sogaard M, Meyhoff CS, Aasvang EK. Continuous Vital Sign Monitoring at the Surgical Ward for Improved Outcomes After Major Noncardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2025 Oct 1;141(4):807-817. doi: 10.1213/ANE.0000000000007606. Epub 2025 Jul 1. |