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

Not Applicable

• Conditions: Device Dislocation
• Interventions: Device: improved version_support device; Device: the NTUH version_support device

• Registration Number: NCT05996055
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-07-31
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
experimental group	improved version_support device	initially using the Type B device (improved version_support device)
experimental group	the NTUH version_support device	initially using the Type B device (improved version_support device)
control group	the NTUH version_support device	initially using the Type A device (the NTUH version_support device)
control group	improved version_support device	initially using the Type A device (the NTUH version_support device)

Primary Outcome Measures

Name	Time	Method
removal time	From date of randomization up to 5 days	the time taken to remove support device
wearing time	From date of randomization up to 5 days	the time taken to wear support device

Secondary Outcome Measures

Name	Time	Method
user self-reported function, and device satisfaction	From date of randomization up to 5 days	self-made questionnaire
adverse event	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.
5-min heart rate variability (HRV)	From date of randomization up to 5 days	including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN)
mean values of the rapid shallow breathing index (RSBI)	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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongzheng, Taiwan