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

NCT ID: NCT05996055

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-01-31

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.

Conditions

Device Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group

initially using the Type A device (the NTUH version\_support device)

Group Type: ACTIVE_COMPARATOR

improved version_support device

Intervention Type: DEVICE

designed the NTUH version\_support device based on the clinical suggestion.

the NTUH version_support device

Intervention Type: DEVICE

original designed by NTUH

experimental group

initially using the Type B device (improved version\_support device)

Group Type: EXPERIMENTAL

improved version_support device

Intervention Type: DEVICE

designed the NTUH version\_support device based on the clinical suggestion.

the NTUH version_support device

Intervention Type: DEVICE

original designed by NTUH

Interventions

improved version_support device

designed the NTUH version\_support device based on the clinical suggestion.

Intervention Type: DEVICE

the NTUH version_support device

original designed by NTUH

Intervention Type: DEVICE

Other Intervention Names

type B support device; type A support device

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Jui Chuang, Dr

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Taipei, Taiwan

Locations

National Taiwan University Hospital

Taipei, Zhongzheng, Taiwan

Countries

Taiwan

Other Identifiers

202303134DINA

Identifier Type: -

Identifier Source: org_study_id