A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization

Conditions
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Device Dislocation

Intervention / Treatment
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* Device: improved version_support device
* Device: the NTUH version_support device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>initially using the Type A device (the NTUH version_support device) | Device: improved version_support device<br>* designed the NTUH version_support device based on the clinical suggestion.<br>* Other names: type B support device;Device: the NTUH version_support device<br>* original designed by NTUH<br>* Other names: type A support device;|
| Experimental: experimental group<br>initially using the Type B device (improved version_support device) | Device: improved version_support device<br>* designed the NTUH version_support device based on the clinical suggestion.<br>* Other names: type B support device;Device: the NTUH version_support device<br>* original designed by NTUH<br>* Other names: type A support device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wearing time | the time taken to wear support device | From date of randomization up to 5 days | 
| removal time | the time taken to remove support device | From date of randomization up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-min heart rate variability (HRV) | including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN) | 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 | From date of randomization up to 5 days | 
| user self-reported function, and device satisfaction | self-made questionnaire | 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. | From date of randomization up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive unit care, Early mobilization, Mechanical ventilation