The aim of this study is to test the hypothesis that continuous wireless monitoring on the postsurgical ward will improve patient outcome, measured as disability-free survival at three months after surgery. Further, we hypothesize that this tight…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Post-operatieve patienten die een intermediar of hoog-risico ingreep ondergaan en-of trauma patienten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Disability-free survival 3 months after surgery (WHODAS 2.0, 12 items)
Secondary outcome
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
Background summary
Every year, approximately 1,500,000 surgical procedures are performed in The
Netherlands. After major surgery, the complication rate is conservatively
estimated at 25%, with a rate of 15% for major complications. In these
patients, the most important problems are a failure to timely detect developing
complications and a failure to adequately rescue those patients. Currently,
measurement of vital signs and standardized assessment of patient wellbeing are
routinely performed intermittently for every 8-12 hours, which may lead to a
failure to detect of patients with complications.
Study objective
The aim of this study is to test the hypothesis that continuous wireless
monitoring on the postsurgical ward will improve patient outcome, measured as
disability-free survival at three months after surgery. Further, we hypothesize
that this tight control regimen decreases length of hospital stay and treatment
costs in patients with complications.
Study design
Interventional, step-wedge, prospective, clinical trial, participating wards
will be included using a stepped-wedge design.
Study burden and risks
All patients, regardless of group allocation, will receive standardized
perioperative care and assessment of vital functions, pain and wellbeing as is
routine clinical patient care in the participating centres. The wards
randomized to undergo continuous wireless monitoring will, in addition, receive
the benefit of real-time monitoring and automated alerts when vital functions
are deviating from baseline. There are no conceivable risks to taking part in
this study, and treatment of complications is at the discretion of the
responsible physician, and not influenced by this study. Therefore, the risk of
study participation is very low.
Kamer H1-130 Meibergdreef 9
Amsterdam 1105 AZ
NL
Kamer H1-130 Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Inability to give written and informed consent
Patient refusal.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02957825 |
| CCMO | NL59154.018.16 |