Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring

Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring - SHEPHERD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49433

Enrollment

1892

Registered

2017-11-27

Start date

2018-02-27

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Post-operatieve patienten die een intermediar of hoog-risico ingreep ondergaan en-of trauma patienten complications after operation Postoperative complications

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing intermediate or high-risk major non-cardiac surgery at the Academic Medical Center Amsterdam (AMC), and the University Medical Center Utrecht (UMCU) or trauma patients

Exclusion criteria

Exclusion criteria: Inability to give written and informed consent Patient refusal.

Design outcomes

Primary

Measure	Time frame
Disability-free survival 3 months after surgery (WHODAS 2.0, 12 items)	—

Secondary

Measure	Time frame
Parameters evaluated at 1 and 3 month after operation (questionnaires as wel preoperatively): • Disability (WHODAS 2.0, 12-item) • EQ-5D-5L score • SF-12 quality of life score (4 week retrospective scorecard) • In-hospital Mortality, 30-day Mortality, 3-month Mortality Parameters evaluated during the admission period: • Patient characteristics (extent of surgery [minor/moderate/major], urgent/elective surgery, duration of surgery, duration of recovery room stay (PACU),) • Length of hospital stay • Discharge destination (other hospital, nursing home, rehabilitation facility, home) • Total number of complications per 100 patients, graded in severity according to Dindo et al.(reference 12 research protocol) and grouped as - Respiratory (e.g., Pneumonia) - Cardiac (e.g., Arrhythmia, Congestive heart failure) - Neurological (e.g., Delirium) - Gastrointestinal (e.g., Anastomotic leakage or Ileus) - Renal (e.g., acute kidney injury) - Other (e.g., Wound dehiscence, Bleeding) • Number of patients with one or more complications - Comprehensive Complication Index 14 - Cost of treatment for complications - Rate of unplanned ICU admissions - ICU admission score (APACHE II15) - ICU length of stay, ventilator free days, inotrope free days - Rate of revision surgery - Rate of false positive alarms - Number of device failures (battery, signal loss) - Rate of alarm responses, grouped according to action - Heart rate variability over time, and as early marker of complications - Quality of sleep	—

Measure

Time frame

Parameters evaluated at 1 and 3 month after operation (questionnaires as wel preoperatively): • Disability (WHODAS 2.0, 12-item) • EQ-5D-5L score • SF-12 quality of life score (4 week retrospective scorecard) • In-hospital Mortality, 30-day Mortality, 3-month Mortality Parameters evaluated during the admission period: • Patient characteristics (extent of surgery [minor/moderate/major], urgent/elective surgery, duration of surgery, duration of recovery room stay (PACU),) • Length of hospital stay • Discharge destination (other hospital, nursing home, rehabilitation facility, home) • Total number of complications per 100 patients, graded in severity according to Dindo et al.(reference 12 research protocol) and grouped as - Respiratory (e.g., Pneumonia) - Cardiac (e.g., Arrhythmia, Congestive heart failure) - Neurological (e.g., Delirium) - Gastrointestinal (e.g., Anastomotic leakage or Ileus) - Renal (e.g., acute kidney injury) - Other (e.g., Wound dehiscence, Bleeding) • Number of patients with one or more complications - Comprehensive Complication Index 14 - Cost of treatment for complications - Rate of unplanned ICU admissions - ICU admission score (APACHE II15) - ICU length of stay, ventilator free days, inotrope free days - Rate of revision surgery - Rate of false positive alarms - Number of device failures (battery, signal loss) - Rate of alarm responses, grouped according to action - Heart rate variability over time, and as early marker of complications - Quality of sleep

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Countries

Netherlands

Outcome results