Ventilator Tube Holder for Patients With a Tracheostomy (TRACHVest)

Ventilator Tube Holder for Patients With a Tracheostomy: A Pilot Usability Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Critical Care

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United Kingdom
  • Cardiff, United Kingdom, CF144XW
    • Cardiff and Vale UHB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critical care

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

• Injuries or restricted movement of the arms or shoulders

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2021
• Primary Completion (ACTUAL): October 31, 2022
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (ACTUAL): March 16, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CED211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No