Early recognition of deterioration in high-risk patients using continuous remote wireless monitoring: a clinical observation study with the Checkpoint Cardio system

Early recognition of deterioration in high-risk patients using continuous remote wireless monitoring: a clinical observation study with the Checkpoint Cardio system - Wireless monitoring for recognition of patient deterioration

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54951

Enrollment

Registered

2020-09-25

Start date

2020-11-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dit betreft een observationele studie met continue metingen van vitale functies bij patiënten met risico op adverse events, welke niet gerelateerd is aan een enkele aandoening of orgaansysteem Not applicable

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * All adult patients (>18 yr of age) who are at high risk for development of serious adverse events receiving care at a surgical or acute medical ward. * Minimum expected duration of hospital stay > 48h

Exclusion criteria

Exclusion criteria: * known allergy/skin irritation to the adhesives used in the recommended commercially ECG electrodes (alternative electrodes may be offered). * implanted active medical devices, such as a cardioverter defibrillator or a pacemaker (to avoid potential interference between the different sensing systems) * a need for contact isolation (to avoid any risk of cross-contamination)

Design outcomes

Primary

Measure	Time frame
Study endpoints for Objective 1 (methods comparison analyses): Respiratory rate, heart rate, blood pressure and arterial blood oxygen saturation derived from sensor data generated during times that the patient is clinically monitored using a wired multi-parameter bedside monitor (for example, while in an operating room, on the recovery room, while admitted to an intensive care or medium care unit). Study endpoints for objective 2 (detection of deterioration): a. the occurrence of clinnical deterioration requiring action by caregivers, and b. the system-calculated deterioration probability and hypothetical alerts generated by the test system (sensing system + clinical decision support software) depending on various deterioration probability thresholds. Study endpoints for objective 3 (usability from a patient perspective): Usability from a patient perspective will be measured with a short patient interview by phone including 8 questions on a 5-point Likert scale and one question with an open answer. Please see appendix 1: usability assessment. For a more expensive explanation of the study outcomes, please refer to section 3.4 (Study Endpoints) of the Research protocol.	—

Measure

Time frame

Study endpoints for Objective 1 (methods comparison analyses): Respiratory rate, heart rate, blood pressure and arterial blood oxygen saturation derived from sensor data generated during times that the patient is clinically monitored using a wired multi-parameter bedside monitor (for example, while in an operating room, on the recovery room, while admitted to an intensive care or medium care unit). Study endpoints for objective 2 (detection of deterioration): a. the occurrence of clinnical deterioration requiring action by caregivers, and b. the system-calculated *deterioration probability* and hypothetical alerts generated by the test system (sensing system + clinical decision support software) depending on various deterioration probability thresholds. Study endpoints for objective 3 (usability from a patient perspective): Usability from a patient perspective will be measured with a short patient interview by phone including 8 questions on a 5-point Likert scale and one question with an open answer. Please see appendix 1: usability assessment. For a more expensive explanation of the study outcomes, please refer to section 3.4 (Study Endpoints) of the Research protocol.

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Secondary

Measure	Time frame
not applicable.	—

Countries

Netherlands

Outcome results