Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05281224 |
| Other study ID # |
CED211 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 21, 2021 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Cardiff and Vale University Health Board |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients admitted to the critical care unit (CCU) at University Hospital Wales (UHW) have a
variety of life-threatening conditions which require specialist care, often including a
period of sedation and mechanical ventilation. As a consequence of critical illness,
survivors often experience multiple sequela, including muscle weakness which leads to reduced
mobility and physical function, especially if they experience a prolonged stay within
critical care. Patients who require mechanical ventilation (MV) usually initially receive
this via an endotracheal tube (ETT), but if the need for MV continues then this support is
delivered through a tracheostomy tube. A small opening is made in the front of the patient's
neck and the tracheostomy tube inserted into the trachea. This is connected to the ventilator
and allows ventilatory support to be delivered without the need for an ETT. Consequently,
sedation levels can be reduced, facilitating improved patient comfort, communication, eating,
drinking and mobilisation.
Early rehabilitation is a key component of a patient's critical care journey and patients are
supported with this by a number of specialist staff including physiotherapists, occupational
therapists, nurses and support workers. Part of this rehabilitation may include helping a
patient to sit on the edge of the bed, stand and mobilise. During rehabilitation sessions and
other aspects of patient care, safety is paramount and staff must take care to ensure all
lines and attachments are not dislodged. This includes tubing connecting the ventilator to
the tracheostomy, excessive movement of which can cause damage to the airway, breakdown of
skin and partial or complete dislodgement requiring immediate intervention.
The number of staff required to help mobilise a patient and maintain safety can be
significant, especially when the patient has several attachments. Unfortunately, this
staffing burden may contribute to reduced levels of patient mobilization and rehabilitation.
However, it is possible that specially designed equipment may facilitate patient mobilization
with increased safety and reduced resource requirements. This study will test a garment that
may achieve this and obtain staff and patient opinion on its utility.
Description:
Patient A was an 85-year-old female with motor neurone disease and a permanent tracheostomy.
She was dependent on a respiratory ventilator, but relatively mobile within the critical care
unit. However, the ventilator tubing connecting the ambulatory ventilator (usually located
behind the patient) to the tracheostomy interfered with the patient's freedom to move and
disturbed the tracheostomy as she changed position. A custom-made garment was designed by the
Medical Engineering Department of Cardiff and Vale University Health Board (CVUHB) to hold
the tubing still and out of the way. This relieved any pressure or pulling on the
tracheostomy tube and allowed the patient greater freedom of movement without requiring
additional staff to manage/handle the tubing. Patient A used the garment every day for
prolonged periods (2-3 hours) and for a duration of 3 months, before she became bedbound and
no longer needed it.
The apparent success of this custom-made garment could be repeated in other patients with
similar conditions. Furthermore, it may help to reduce the number of staff required when
mobilising a patient and lower the handling burden. This project is intended to explore the
use of such a garment in a critical care setting. Patients who can be moved out of bed may be
moved several times a day, requiring 3 or more staff members each time. If the garment holds
the connector tubing securely during these movements then there are several potential
benefits:
- Fewer staff may be required to move the patient
- Improved manual handling processes for staff
- Reduction in adverse events associated with mobilisation
- Improved patient comfort during mobilisation Even small movements of the tracheostomy
tube can cause discomfort and coughing, whereas larger movements risk tissue damage,
airway trauma or dislodging the tracheostomy. In addition, the patient may have more
freedom of movement when using the garment out of bed.
However, it is uncertain if or how the current design of the garment will impact on staff and
patient activities. There are several potential disadvantages of using the garment:
- It may be awkward to put on and take off, especially for patients with multiple device
connections and/or cannulas, limited upper body mobility, and/or cognitive impairment
- It may interfere with the use of a hoist
- As a result, it may increase the time and/or staff members needed to move the patient
- It may increase motion of the tracheostomy tube resulting in greater discomfort and risk
of tissue damage or disruption of the ventilation
- It may be uncomfortable or too hot for the patient
- Staff may become dependent on the garment and be less vigilant of the tubing.
Essentially, the study will observe staff using the garment to determine where the
potential benefits and limitations exist.
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