Device DislocationNCT05996055
A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients
A study testing improved version_support device and the NTUH version_support device in people with Device Dislocation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Assisting critically ill patients with early mobilization or early ambulation during their stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use, length of ICU or hospital stay, probability of complications during hospitalization, and sedation days in the ICU and improve disease… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Device Dislocation
- What is being tested?
- improved version_support device and the NTUH version_support device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2023to 31 Jan 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma Scale score of ≥6,
- relatively stable respiratory status (oxygen saturation >92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O)
- a stable cardiovascular system (resting heart rate ≤130 and >40 beats per minute)
- no requirement for high-dose vasopressors >0.2 μg/kg/min).
Who cannot join
- Patients with temporary limb immobilization as prescribed by the physician.
- Patients with a tendency to bleed.
- Patients with pre-existing mental abnormalities.
- Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit.
- Patients with sustained intracranial pressure elevation (> 20 millimeters of mercury (mmHg)).
- Pregnant patients.
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- Uncontrolled epilepsy.
- Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in the intensive care unit.
- Patients with abnormal skin conditions such as skin abrasions, redness, swelling, etc., in the chest/back area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization
Assisting critically ill patients with early mobilization or early ambulation during their stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use, length of ICU or hospital stay, probability of complications during hospitalization, and sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill patients have endotracheal tubes and require the use of mechanical ventilators in the ICU, and due to the numerous invasive treatments and tubes, there are high concerns regarding the safety of tube stability and risk of tube dislodgement during early mobilization. Although there are commercially available fixed tracheal tubes or external support devices for breathing tubes to prevent displacement, they do not solve the problems of the weight of the breathing tube during ambulation or endotracheal tube slippage. Therefore, through interdisciplinary collaboration, the investigator has designed a "wearable support device" (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the displacement of the free section of the endotracheal tube downwards, it can also fix the main body of the breathing tube. The dual-disc strap method allows adjustment of the position and tightness for patients of different body sizes, and a single specification can be used for patients of various body shapes. Currently, a modified version of this wearable support device (Type B support device) has been designed based on clinical suggestions.The purpose of this study is to compare the feasibility, safety, and comfort of using the Type A-support device and the Type B-support device to assist in supporting breathing tubes during early ambulation in ICU patients using mechanical ventilators.
- Conditions
- Device Dislocation
- Being tested
- improved version_support device, the NTUH version_support device
- Keywords
- Intensive unit care, Early mobilization, Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improved version_support deviceDevice
Also called type B support device
designed the NTUH version_support device based on the clinical suggestion.
the NTUH version_support deviceDevice
Also called type A support device
original designed by NTUH
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | initially using the Type A device (the NTUH version_support device) Receives: Device: improved version_support device; Device: the NTUH version_support device |
| experimental group | Experimental | initially using the Type B device (improved version_support device) Receives: Device: improved version_support device; Device: the NTUH version_support device |
What is being measured
The primary outcome is the main question the study is designed to answer.
wearing time
the time taken to wear support device
Measured: From date of randomization up to 5 days
removal time
the time taken to remove support device
Measured: From date of randomization up to 5 days
Secondary outcomes (4)
5-min heart rate variability (HRV)
including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN)
Measured: From date of randomization up to 5 days
mean values of the rapid shallow breathing index (RSBI)
recorded the ratio of respiratory rate (RR) and tidal volume (VT) and calulated by RR to VT
Measured: From date of randomization up to 5 days
user self-reported function, and device satisfaction
self-made questionnaire
Measured: From date of randomization up to 5 days
adverse event
Observe the abnormality of the skin on the chest/back of the base plate before and after wearing it; Record the number of incidents of accidental slippage of the external oral line while performing early ambulation while wearing the support device.
Measured: From date of randomization up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start31 Jul 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device DislocationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Jui Chuang, Dr, Principal investigator, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996055
- Sponsor's protocol ID
- 202303134DINA
- Status last verified
- Jun 2024
- First submitted
- 31 Jul 2023
- Last updated
- 23 Sep 2024
- Results posted
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization
- ClinicalTrials.gov ID
- NCT05996055
- Acronym / sponsor ID
- 202303134DINA
- Conditions
- Device Dislocation
- Keywords
- Intensive unit care, Early mobilization, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 16 Aug 2023 (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.
Assisting critically ill patients with early mobilization or early ambulation during their stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use, length of ICU or hospital stay, probability of complications during hospitalization, and sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill patients have endotracheal tubes and require the use of mechanical ventilators in the ICU, and due to the numerous invasive treatments and tubes, there are high concerns regarding the safety of tube stability and risk of tube dislodgement during early mobilization. Although there are commercially available fixed tracheal tubes or external support devices for breathing tubes to prevent displacement, they do not solve the problems of the weight of the breathing tube during ambulation or endotracheal tube slippage. Therefore, through interdisciplinary collaboration, the investigator has designed a "wearable support device" (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the displacement of the free section of the endotracheal tube downwards, it can also fix the main body of the breathing tube. The dual-disc strap method allows adjustment of the position and tightness for patients of different body sizes, and a single specification can be used for patients of various body shapes. Currently, a modified version of this wearable support device (Type B support device) has been designed based on clinical suggestions.The purpose of this study is to compare the feasibility, safety, and comfort of using the Type A-support device and the Type B-support device to assist in supporting breathing tubes during early ambulation in ICU patients using mechanical ventilators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: improved version_support device, Device: the NTUH version_support deviceinitially using the Type A device (the NTUH version_support device) |
| experimental group | Experimental | Device: improved version_support device, Device: the NTUH version_support deviceinitially using the Type B device (improved version_support device) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glasgow Coma Scale score of ≥6,
- relatively stable respiratory status (oxygen saturation >92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O)
- a stable cardiovascular system (resting heart rate ≤130 and >40 beats per minute)
- no requirement for high-dose vasopressors >0.2 μg/kg/min).
Key exclusion criteria (9 listed)
- Patients with temporary limb immobilization as prescribed by the physician.
- Patients with a tendency to bleed.
- Patients with pre-existing mental abnormalities.
- Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit.
- Patients with sustained intracranial pressure elevation (> 20 millimeters of mercury (mmHg)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| improved version_support deviceAlso: type B support devicedesigned the NTUH version_support device based on the clinical suggestion. | Device | control group, experimental group |
| the NTUH version_support deviceAlso: type A support deviceoriginal designed by NTUH | Device | control group, experimental group |
Primary outcome
wearing time
Time frame: From date of randomization up to 5 days
the time taken to wear support device
removal time
Time frame: From date of randomization up to 5 days
the time taken to remove support device
4 secondary outcomes
5-min heart rate variability (HRV)
Time frame: From date of randomization up to 5 days
mean values of the rapid shallow breathing index (RSBI)
Time frame: From date of randomization up to 5 days
user self-reported function, and device satisfaction
Time frame: From date of randomization up to 5 days
adverse event
Time frame: From date of randomization up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Hung-Jui Chuang, Dr principal investigator
National Taiwan University Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing improved version_support device and the NTUH version_support device in people with Device Dislocation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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 Taiwan. 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?
Results are not available in the source record.
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?
wearing time (time frame: From date of randomization up to 5 days). The study lists 2 primary outcomes in all. 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 23 Sep 2024.