Supporting early recognition of clinical deterioration for Mobile Vital signs monitoring of high-risk surgical patients

Completed

Conditions: Pre- en postoperatieve complicaties bij hoog-risico chirurgie
: complications
clinical deterioration
10017998

Registration Number: NL-OMON50879

Lead Sponsor: Ziekenhuisgroep Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

The study population includes two patient groups:
1. Patients aged (18 years and older) undergoing elective surgery for resection
of malignant
tumors of the upper gastrointestinal tract (upper GI patients)
2. Patients aged (70 years and older) undergoing surgery for a hip fracture and
admitted to the
hospital for pre- or postoperative care (hip fracture patients)

Exclusion Criteria

1. Contraindications for use of vital sign sensor patch (i.e. skin allergy,
implanted medical devices)
2. Contact isolation

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study will result in the development of a model for prediction of<br /><br>deterioration requiring escalation of care. The model performance will be<br /><br>assessed in terms of sensitivity and false discovery rate for prediction of<br /><br>deterioration requiring escalation of care within 24 hours, and compared with<br /><br>the currently used Modified Early Warning Score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The study will result in:<br /><br>- Insight in patterns of deterioration, which will be described as<br /><br>characteristics (slopes, absolute values, ratio*s, etc.) observed in vital sign<br /><br>and routine clinical measurements<br /><br><br /><br>- Insight in methods that can support personalized detection of patters of<br /><br>deterioration<br /><br>- Insight in the potential clinical value of models for prediction of<br /><br>deterioration, which will assessed using the time between prediction of<br /><br>deterioration and current clinical response and compared with the currently<br /><br>used Modified Early Warning Score. </p><br>