Objective: To study the effect(s) of Thekla use as a mobilization device in a thorax intensive care setting on mechanicallyventilated critically ill patients and see if this leads to a reduction on TICU stay. Outcomes could possibly stimulate…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
HR, BP, pH, pCO2, pO2, BE,B, HCO3, sO2, length of stay on TICU, costs-benefits,
staff and patient experience
Secondary outcome
n/a
Background summary
Two previous descriptive studies have been conducted. One at the
Universitatsklinik Essen *Bewegingstherapie en
mobilisatie in een vroeg stadium bij polytraumapatienten met de
Thekla-revalidatierolstoel; Wolfgang Schirsching, Hans-
Jurgen Wihs* and the other at the MST. Both studies failed in providing
evidence based conclusions. However experience
indicates that mobilizing critically ill patients in an early stage of recovery
with the Thekla, may positively contribute to postoperative recovery.
No studies regarding the Thekla have been published in scientific journals.
Similar studies involving other verticalization
devices have been conducted and published. However, these numbers are small.
The results of two studies involving
verticalization are summarized in an overview. These previous studies suggest
that there may be a positive effect of
verticalization on the physiological processes in critically ill patients. This
invites for further research. The study *Thekla on the TICU* can be considered
a follow up study.
The social relevance of this study is covered by investigating length of stay
on TICU, patient experiences and medical
changes, staff experience (labour related aspects) and a cost-benefit analysis
will be made. To our knowledge, these afore
mentioned aspects have not been studied previously.
Mobilizing mechanically ventilated critically ill patients is accompanied by
risks. These patients become easily unstable and
death is close. Before initiating mobilizations, safety aspects should be
considered. Studies done by Stiller and Phillips give a clear overview of the
aspects that need to be covered prior and during mobilizing critically ill
patients on an intensive care
unit. These studies include a chart that serves as a guideline to safely
mobilize these patients.
Study objective
Objective: To study the effect(s) of Thekla use as a mobilization device in a
thorax intensive care setting on mechanically
ventilated critically ill patients and see if this leads to a reduction on TICU
stay. Outcomes could possibly stimulate the
mobilization of patients with the Thekla.
To quantify the effect(s) and analyze the efficacy of Thekla use in an early
stage of recovery on mechanically ventilated
critically ill patients on the Thorax Intensive Care Unit within a study
duration of 4 months. This will be realized by means of
recordings, blood gas analysis, data analysis, questionnaires and a literature
study.
Sub-objectives:
- Cost-benefit analysis
- Evaluate Thekla experience of nursing staff
- Measure the effects on the circulatory and respiratory system
- Evaluate patient experience of Thekla mobilizations
Study design
Randomized controlled pilot study
Intervention
Thekla mobilizations (60° verticalization for >=15 minutes) and regular therapy
(n=15) vs. regular therapy (n=15)
Study burden and risks
Thekla verticalization does increase the risk of becoming hemodynamic unstable.
Upon TICU discharge each patient from the intervention group is asked to fill
in a questionnaire. Some of these patients will also be questioned orally.
Depending on patient response, a numeric rating scale to assess quality of life
will be acquired in both groups daily. Throughout TICU stay blood samples will
be acquired daily (06:00 AM) to measure blood gas values. In the intervention
group one additional blood sample is taken 10 minutes after Thekla mobilization
on the first 7 days. This will be withdrawn from an arterial line that is
already placed, therefore no extra invasive procedures are needed. Positive
effects in lung function is expected. When this study shows that use of Thekla
leads to a reduction in stay on the TICU, it could be beneficial for other
patients. Physical loading of nursing staff and physiotherapists may be
reduced. Also financial benefits could be a positive outcome of this study,
since TICU stay is expensive.
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Haaksbergerstraat 55
7513 ER Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Cardiovascular criteria: resting heart rate <120 beats per minute, blood pressure <20% variability recently and normal ECG.
Respiratory criteria: SpO2 >90% and <4% recent decrease in SpO2, respiratory rate <35 breaths per minute and mechanical ventilation needs to be able to be maintained during treatment.
Additional criteria: haemoglobin stable and >4.8 gramms/dL, platelet count stable and >50,000 cells/mm3, white cell count 4,300 - 10,800 cells/mm3, body temperature <38°C, blood glucose level 3.5 -12 mmol/L, patient must not experience excessive pain/ fatigue/ shortness of breath and the emotional status must be acceptable.
Exclusion criteria
Patients receiving other interventions than regular mobilization therapy (considered to be; active, active-assisted and passive range of motion exercises for all limbs, breathing exercises, sputum clearance and transfers performed are supine to sit, from bed to chair and pre-walking exercises) provided by nursing staff and/or physiotherapists, <18 years of age, enrollment in another trial, evidence of postoperative myocardial infarction or arrhythmia, orthopedic contraindications, recent split skin graft/ flap to lower limbs or trunk, >150 kg of weight, Intra Aortic Balloon Pump, Continuous Veno - Venous Hemofiltration in groin, arterial line in groin, deep venous thrombosis, pulmonary embolism, neurological contraindications or no Dutch language proficiency.
Design
Recruitment
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 | NL29434.044.09 |