An observational study in Critical Care, sponsored by Cardiff and Vale University Health Board. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Cardiff and Vale University Health Board · Observational
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.
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:
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:
Cardiff and Vale University Health Board is the lead sponsor of 44 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critical care
Exclusion Criteria:
Staff opinion on potential to change occurrence of adverse events using TrachVest
User feedback via questionnaires and focus groups to determine its potential to reduce adverse events. Questionnaires will be non-validated. Focus groups to follow structured questions.
Time frame: 6 months
Perceived benefits of the TrachVest on staff time
User feedback via questionnaires and focus groups to determine its potential to reduce staff time. Questionnaires will be non-validated for staff and patients. Staff focus groups to follow structured questions.
Time frame: 6 months
Perceived benefits of the TrachVest on patient comfort
User feedback via questionnaires and focus groups to determine its potential to improve patient comfort. Questionnaires will be non-validated for staff and patients. Staff focus groups to follow structured questions.
Time frame: 6 months
Usability of the TrachVest
User feedback via questionnaires and focus groups to determine its usability within critical care. Questionnaires will be non-validated for staff and patients. Staff focus groups to follow structured questions.
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Cardiff and Vale University Health Board