Primary Objective: To investigate in surgical ward patients whether the use of wireless continuous vital signs monitoring will reduce total length of hospital stay.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
post-operatieve complications (rebleeding, infection, myocardial infarction etc)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the total length of hospital stay
Secondary outcome
Secondary endpoints: cardiac arrests, mortality, unplanned ICU admissions,
30-day readmission, RRT calls
Other study parameters are age, gender, % acute admission, charlson comorbidity
index (CCI), international classification disease (ICD), limitation of medical
treatment (LOMT).
Background summary
In the last decades 10% of all clinically admitted patients in hospitals
experienced harm, of which at least 33% of the most severe incidents was due to
failure to recognize and treat the deteriorating patient timely on the general
wards. Therefore, to improve early recognition and adequate treatment for
deteriorating patients, Rapid Response Teams (RRT) have been introduced
worldwide since 1995 During a first Consensus meeting it was stated that
hospitals should implement an rapid response system (RRS), which consists of
four elements: an afferent, "crisis detection" and "response triggering"
mechanism; an efferent, predetermined rapid response team; a
governance/administrative structure to supply and organize resources; and a
mechanism to evaluate crisis antecedents and promote hospital process
improvement to prevent future events, thus implementing a system rather than a
team.
But even in hospitals with an established mature RRS, failure to rescue events
occur, mostly related to the *afferent limb* of the system, e.g. failure to
identify patients at risk. One of the key underlying mechanisms is that the
present Rapid Response System (RRS) is based on intermittent monitoring (*spot
checks*) every 6-12 hours which may lead to failure to detect a deteriorating
patient timely.
For example, a recent study showed that 47% of postoperative patients develop
hypotensive periods with a mean arterial pressure < 65 mmHg for at least 15
minutes, while another study showed that more than one third of surgical
patients experience an oxygen saturation level of <90% for an hour or more.
Earlier trials showed that continuous monitoring on the general ward (*low
care* environments) was associated with a reduced need for patient rescue
events or unplanned ICU admissions
Therefore, our aim is to investigate whether wireless continuous vital signs
monitoring contributes to timely recognition and treatment of the deterioration
patient on a surgical ward resulting in a reduced total hospital length of
stay.
Study objective
Primary Objective: To investigate in surgical ward patients whether the use of
wireless continuous vital signs monitoring will reduce total length of hospital
stay.
Study design
Prospective, interventional single arm trial with historical controls.
The duration of the study is from april 6th to October 5th 2021.
Setting is a general ward in a large European teaching hospital.
Intervention
The intervention group receives at admission continuous monitoring provided by
a wireless patch (CE marked; class2a), worn on the patient*s chest, with data
transmitted wirelessly every 2 minutes to a mobile device carried by the
patient*s nurse.
Study burden and risks
Apart of wearing a wireless patch during the stay at the general ward and
completing a single short questionnaire on their experience with wearing a
patch, which will take 5-10 minutes, the nature and extent of the burden and
risks are minimal to none.
Albert Schweitzerplaats 25
Dordrecht 3000AK
NL
Albert Schweitzerplaats 25
Dordrecht 3000AK
NL
Listed location countries
Age
Inclusion criteria
At least 18 years old; surgical, gastroenterology and gynaecological oncology
surgical admissions; expected length of stay > 24 h; informed consent
Exclusion criteria
An allergy to skin adhesives, wound or skin lesion near the application site,
patients with a pacemaker or implantable cardioverter defibrillator, patients
in a palliative trajectory, patients waiting for placement in a nursery home.
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
In other registers
Register | ID |
---|---|
CCMO | NL77132.041.21 |
OMON | NL-OMON26077 |