A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients
September 19, 2024 updated by: National Taiwan University Hospital
Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhongzheng
-
Taipei, Zhongzheng, Taiwan, 110
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Glasgow Coma Scale score of ≥6,
- relatively stable respiratory status (oxygen saturation >92%, settings on the mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory pressure ≤10 cmH2O)
- a stable cardiovascular system (resting heart rate ≤130 and >40 beats per minute)
- no requirement for high-dose vasopressors >0.2 μg/kg/min).
Exclusion Criteria:
- Patients with temporary limb immobilization as prescribed by the physician.
- Patients with a tendency to bleed.
- Patients with pre-existing mental abnormalities.
- Patients who are expected to die within the next 24 hours or are primarily receiving palliative care in the intensive care unit.
- Patients with sustained intracranial pressure elevation (> 20 millimeters of mercury (mmHg)).
- Pregnant patients.
- Uncontrolled epilepsy.
- Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in the intensive care unit.
- Patients with abnormal skin conditions such as skin abrasions, redness, swelling, etc., in the chest/back area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
initially using the Type A device (the NTUH version_support device)
|
designed the NTUH version_support device based on the clinical suggestion.
Other Names:
original designed by NTUH
Other Names:
|
|
Experimental: experimental group
initially using the Type B device (improved version_support device)
|
designed the NTUH version_support device based on the clinical suggestion.
Other Names:
original designed by NTUH
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wearing time
Time Frame: From date of randomization up to 5 days
|
the time taken to wear support device
|
From date of randomization up to 5 days
|
|
removal time
Time Frame: From date of randomization up to 5 days
|
the time taken to remove support device
|
From date of randomization up to 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
5-min heart rate variability (HRV)
Time Frame: From date of randomization up to 5 days
|
including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN)
|
From date of randomization up to 5 days
|
|
mean values of the rapid shallow breathing index (RSBI)
Time Frame: From date of randomization up to 5 days
|
recorded the ratio of respiratory rate (RR) and tidal volume (VT) and calulated by RR to VT
|
From date of randomization up to 5 days
|
|
user self-reported function, and device satisfaction
Time Frame: From date of randomization up to 5 days
|
self-made questionnaire
|
From date of randomization up to 5 days
|
|
adverse event
Time Frame: From date of randomization up to 5 days
|
Observe the abnormality of the skin on the chest/back of the base plate before and after wearing it; Record the number of incidents of accidental slippage of the external oral line while performing early ambulation while wearing the support device.
|
From date of randomization up to 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hung-Jui Chuang, Dr, National Taiwan University Hospital, Taipei, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2023
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
September 23, 2024
Last Update Submitted That Met QC Criteria
September 19, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202303134DINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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