Critical CareTRACHVestNCT05281224
Ventilator Tube Holder for Patients With a Tracheostomy
An observational study of Critical Care, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical care
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Injuries or restricted movement of the arms or shoulders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Care
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start21 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281224
- Sponsor's protocol ID
- CED211
- Acronym
- TRACHVest
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2021
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Tube Holder for Patients With a Tracheostomy: A Pilot Usability Study Protocol
- ClinicalTrials.gov ID
- NCT05281224
- Acronym / sponsor ID
- TRACHVest / CED211
- Conditions
- Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical care
Key inclusion criteria (9 listed)
- Inpatient on critical care unit for any admitting condition
- Aged over 18
- Any gender
- A permanent or temporary tracheostomy
- Dependant on a respiratory ventilator
Key exclusion criteria (1 listed)
- Injuries or restricted movement of the arms or shoulders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Staff opinion on potential to change occurrence of adverse events using TrachVest
Time frame: 6 months
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.
3 secondary outcomes
Perceived benefits of the TrachVest on staff time
Time frame: 6 months
Perceived benefits of the TrachVest on patient comfort
Time frame: 6 months
Usability of the TrachVest
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Critical Care
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staff opinion on potential to change occurrence of adverse events using TrachVest (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.