N/A
N=60
Assessment of a Novel Tracheostomy Tie
Tracheostomy Complication
Bottom Line
View on ClinicalTrials.gov: NCT02820181 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome — 1.2; 7.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- novel tracheostomy bi-ties (Device); traditional Tracheostomy ties (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The First Affiliated Hospital of Shanxi Medical University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome |
1.2; 7.5 | — |
| PRIMARY Number of Participants With Local Skin Breakdown |
30; 27; 0; 2; 0; 1 | — |
| SECONDARY Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome. |
1.0; 8.9 | — |
| SECONDARY Objective Index:the Actually Frequency of Exchanging Dressing |
0; 2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02820181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.