Assessment of a Novel Tracheostomy Tie

Study Overview
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Brief Summary
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Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged as needed. However, the process of ties exchange is always risky and complicated. A novel tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of cleaning. This study is to determine if the new device is better than the old one.

Detailed Description
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Tracheotomy is a common procedure for multiple medical indications. Nursing staff must understand the immediate postoperative and long-term management of tracheostomy patients. To provide safe and competent care, tracheostomy tubes must be taken care of carefully, including cleaning or changing the inner cannula, caring for the stoma, suctioning at least 3 times a day, and replacing tracheostomy ties according to facility-specific policy as needed. However, to avoid inadvertent dislodgement of the tracheostomy tube, the process of ties exchange is always risky and complicated, which request one person to hold the tube in place while a second person performs the tie exchange. The investigators designed a novel tracheostomy tie to ensure the safety during exchanging and conveniences of cleaning, the primary feature of which is double belts and easy to operate. This randomized controlled trial is to determine if the new device is better than the traditional one. Sixty tracheotomy patients without an existing neck injury will be recruited . Patients in experimental group wear a novel tracheostomy tie. The traditional one was used in control group. Difficulty level of exchanging or cleaning the tracheostomy ties, degree of comfort, skin breakdown and the actually frequency of exchanging will be evaluated.

Official Title
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Assessment of Functionality and Performance of a Novel Tracheostomy Tie

Conditions
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Tracheostomy Complication

Intervention / Treatment
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* Device: novel tracheostomy bi-ties
* Device: traditional Tracheostomy ties


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 18 years old and ≤ 60 years old; Patients with a tracheostomy; With intact neck skin; Willingly signs the Informed Consent; Is qualified to participate in the opinion of the Investigator; Without disorders of consciousness. Exclusion Criteria: With an existing neck injury or infection or clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer; With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site; Has a known or stated allergy to adhesive bandages, or any of the product types being tested; Uses of topical drugs on the application site; Uses lotions, creams or oils on the application site; Can not communicate with nurses or doctors for any reasons

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: novel tracheostomy bi-ties<br>those with the novel tracheostomy bi-ties | Device: novel tracheostomy bi-ties<br>* The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.<br>|
| Active Comparator: traditional tracheostomy tie<br>those with traditional tracheostomy tie | Device: traditional Tracheostomy ties<br>* Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome | Nurses will be evaluated by Visual Analogue Scale/Score to measure the difficulty level of exchanging or cleaning the tracheostomy ties. Title: Visual Analogue Scale to measure the difficulty level of exchanging or cleaning the tracheostomy ties (0 to 10 ) Higher scores mean a worse outcome | 14days | 
| Number of Participants With Local Skin Breakdown | Scale for breakdown of neck skin wound was rated as mild, moderate, or severe. Mild wounds included fragile skin that was erythematous or had a small amount of breakdown (<1 cm in diameter). Wounds with evident skin erosion or breakdown associated with drainage and/or pain were classified as moderate. Severe wounds were defined as a partial-thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed. | 14days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome. | Visual Analogue Scale/Score will be used to measure the degree of comfort of patients during wearing or exchanging tracheostomy ties Title: Visual Analogue Scale of comfort of patients during wearing or exchanging tracheostomy ties(0-10) Higher scores mean worse outcome. | 14days | 
| Objective Index:the Actually Frequency of Exchanging Dressing | The record of the frequency of exchanging dressing under the tracheostomy ties in practice will be collected | 14days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tracheostomy ties