NCT05996055

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

Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	improved version_support device	designed the NTUH version\_support device based on the clinical suggestion.
DEVICE	the NTUH version_support device	original designed by NTUH

Timeline

• Start date: 2023-07-31
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2023-08-16
• Last updated: 2024-09-23

Locations

1 site across 1 country: Taiwan