Clinical trial NCT05996055: A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients
Official title: Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Device Dislocation
Keywords: Intensive unit care
Early mobilization
Mechanical ventilation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: wearing time
timeFrame: From date of randomization up to 5 days
measure: removal time
timeFrame: From date of randomization up to 5 days
Secondary outcomes:
measure: 5-min heart rate variability (HRV)
timeFrame: From date of randomization up to 5 days
measure: mean values of the rapid shallow breathing index (RSBI)
timeFrame: From date of randomization up to 5 days
measure: user self-reported function, and device satisfaction
timeFrame: From date of randomization up to 5 days
measure: adverse event
timeFrame: From date of randomization up to 5 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
Study officials:
affiliation: National Taiwan University Hospital, Taipei, Taiwan
name: Hung-Jui Chuang, Dr
role: PRINCIPAL_INVESTIGATOR
References: