Viewing Study NCT05996055



Ignite Creation Date: 2024-05-06 @ 7:23 PM
Last Modification Date: 2024-10-26 @ 3:06 PM
Study NCT ID: NCT05996055
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-08-16
First Post: 2023-07-31

Brief Title: A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: 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
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 patients 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 suggestionsThe 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None