Device Dislocation
Conditions
Keywords
Intensive unit care, Early mobilization, Mechanical ventilation
Brief 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 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.
Interventions
DEVICEimproved version_support device
designed the NTUH version\_support device based on the clinical suggestion.
DEVICEthe NTUH version_support device
original designed by NTUH
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Glasgow Coma Scale score of ≥6, 2. relatively stable respiratory status (oxygen saturation \>92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O) 3. a stable cardiovascular system (resting heart rate ≤130 and \>40 beats per minute) 4. no requirement for high-dose vasopressors \>0.2 μg/kg/min).
Exclusion criteria
1. Patients with temporary limb immobilization as prescribed by the physician. 2. Patients with a tendency to bleed. 3. Patients with pre-existing mental abnormalities. 4. Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit. 5. Patients with sustained intracranial pressure elevation (\> 20 millimeters of mercury (mmHg)). 6. Pregnant patients. 7. Uncontrolled epilepsy. 8. Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in the intensive care unit. 9. Patients with abnormal skin conditions such as skin abrasions, redness, swelling, etc., in the chest/back area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wearing time | From date of randomization up to 5 days | the time taken to wear support device |
| removal time | From date of randomization up to 5 days | the time taken to remove support device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-min heart rate variability (HRV) | From date of randomization up to 5 days | including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN) |
| mean values of the rapid shallow breathing index (RSBI) | From date of randomization up to 5 days | recorded the ratio of respiratory rate (RR) and tidal volume (VT) and calulated by RR to VT |
| user self-reported function, and device satisfaction | From date of randomization up to 5 days | self-made questionnaire |
| adverse event | From date of randomization up to 5 days | 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. |
Countries
Taiwan
Outcome results
None listed