Clinical trial NCT02820181: Assessment of a Novel Tracheostomy Tie
Official title: Assessment of Functionality and Performance of a Novel Tracheostomy Tie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complication
Keywords: tracheostomy ties
Lead sponsor: The First Affiliated Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects ≥ 18 years old and ≤ 60 years old;
2. Patients with a tracheostomy;
3. With intact neck skin;
4. Willingly signs the Informed Consent;
5. Is qualified to participate in the opinion of the Investigator;
6. Without disorders of consciousness.

Exclusion Criteria:

1. 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;
2. With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site;
3. Has a known or stated allergy to adhesive bandages, or any of the product types being tested;
4. Uses of topical drugs on the application site;
5. Uses lotions, creams or oils on the application site;
6. Can not communicate with nurses or doctors for any reasons

Primary outcomes:
measure: Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome
timeFrame: 14days
measure: Number of Participants With Local Skin Breakdown
timeFrame: 14days
Secondary outcomes:
measure: Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome.
timeFrame: 14days
measure: Objective Index:the Actually Frequency of Exchanging Dressing
timeFrame: 14days
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Binquan Wang
role: STUDY_DIRECTOR
References: