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

National Taiwan University

Status: Active, not recruiting

Conditions: Device Dislocation

Treatments: Device: improved version_support device; Device: the NTUH version_support device

Study type: Interventional

Funder types: Other

Identifiers

NCT05996055

202303134DINA

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

control group

Active Comparator group

Description:

initially using the Type A device (the NTUH version_support device)

Treatment:

Device: the NTUH version_support device

Device: improved version_support device

experimental group

Experimental group

Description:

initially using the Type B device (improved version_support device)

Treatment:

Device: the NTUH version_support device

Device: improved version_support device