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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | initially using the Type A device (the NTUH version_support device) |
|
| experimental group | Experimental | initially using the Type B device (improved version_support device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| improved version_support device | Device | designed the NTUH version_support device based on the clinical suggestion. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hung-Jui Chuang, Dr | National Taiwan University Hospital, Taipei, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Zhongzheng | 110 | Taiwan |
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| the NTUH version_support device | Device | original designed by NTUH |
|
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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 |