Ventilator Tube Holder for Patients With a Tracheostomy

NCT05281224 | Completed

• 1 other identifier: CED211
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Care

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Perceived benefits of the TrachVest on staff time

  6 months

• Perceived benefits of the TrachVest on patient comfort

  6 months

• Usability of the TrachVest

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical care

You may qualify if:

• \- Inpatient on critical care unit for any admitting condition
• Aged over 18
• Any gender
• A permanent or temporary tracheostomy
• Dependant on a respiratory ventilator
• Capable and expected to be out of bed and mobile on the critical care unit with the assistance of staff
• Expected to remain on critical care unit for several days, and to retain their tracheostomy during this time.
• Not currently Covid-positive (defined by local policy) and in area of reduced requirement for personal and protective equipment
• Is able to give written, informed consent or have an appropriate consultee who can be approached

You may not qualify if:

• Injuries or restricted movement of the arms or shoulders

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Cardiff and Vale UHB

Cardiff, CF144XW, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: March 16, 2022
• Study Start: October 21, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)