The aim of the study is to investigate whether the use of telemetry monitoring leads to the promotion of early mobilization, by an improvement in mobilization and strength measurements, in rehabilitating ICU/MCU patients. Secondary goal is whether…
ID
Source
Brief title
Condition
- Other condition
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>Primary Goal:<br />
- Early mobilization measured by DEMMI score (within 24-48 hours after<br />
inclusion of the study and then twice a week by physiotherapist)<br />
- Muscle strength measured by MRC-SUM (within 24-48 hours after inclusion of<br />
the study and then twice a week by physiotherapist)</p>
Secondary outcome
<p>- Reducing anxiety and depression measured by HADS score at the time of<br />
inclusion of the study and in the first hours after discharge to the ward.<br />
- Feeling more safe measured by one question at the time of inclusion of the<br />
study and in the first hours after discharge to the ward.</p>
Background summary
Increasingly, Intensive and Medium Care unit (ICU/MCU) patients stay longer in
the ICU/MCU for several reasons. These patients still have an ICU/MCU
indication, but vital signs no longer need to be intensively monitored. These
patients are no longer critically ill, but are in a rehabilitation stage. They
still receive continuous monitoring until discharge to the ward. Early
mobilization is one of the most important interventions in this rehabilitation
stage but bedside monitoring limits patient's freedom and mobilization
possibilities.
Study objective
The aim of the study is to investigate whether the use of telemetry monitoring
leads to the promotion of early mobilization, by an improvement in mobilization
and strength measurements, in rehabilitating ICU/MCU patients.
Secondary goal is whether this telemetry monitoring reduces stress and anxiety
around discharge to the ward (without continuous monitoring vital signs).
Study design
Randomized control trial with an unblinded intervention and control group.
Intervention
The intervention means monitoring with telemetry until discharge to the ward.
The control group maintains conventional bedside monitoring until discharge to
the ward.
Study burden and risks
The rehabilitating ICU/MCU patient receives more appropriate vital signs
monitoring care, which may have a positive effect on early mobilization and may
also reduce stress and anxiety and increase the sense of security around
transfer to the ward without continuous monitoring vital signs.
A pilot study at the MCU in the St. Antonius hospital (2022) has already shown
that the introduction of telemetry monitoring is safe and accepted by
healthcare professionals on the MCU.
I van de Pol
Koekoekslaan 1
Nieuwegein 3435 CM
Netherlands
0883206614
i.van.de.pol@antoniusziekenhuis.nl
I van de Pol
Koekoekslaan 1
Nieuwegein 3435 CM
Netherlands
0883206614
i.van.de.pol@antoniusziekenhuis.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
• >=18 years
• Minimum ICU/MCU stay 5 days
• No expected discharge to the ward without continuous monitoring vital signs
within 48 hours
• Meets pre-defined criteria:
o Hemodynamic stability
o No use of inotropes/vasopressors
o Not external pacemaker dependent
o No significant cardiac arrhythmia or intervention in the last 48 hours
• No arterial pressure catheter/line
• Signed informed consent
Exclusion criteria
- CVA during hospital admission, with limited mobility (hemiparesis)
- Paraplegia due to myelum ischemia after aortic surgery
- Guillain-Barre
- Prescribed bed rest (e.g. type B dissection)
- No signed informed consent
- Not instructable or limited mobility
- Patient has already been included in the study during hospital admission
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| CCMO | NL84541.100.23 |
| Research portal | NL-006139 |