Assessment of a Novel Tracheostomy Tie

NCT02820181 | Completed Results

• 1 other identifier: FirstTianjunENT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheostomy Complication

Keywords

tracheostomy ties

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

  14days

Study Arms (2)

novel tracheostomy bi-ties

EXPERIMENTAL

those with the novel tracheostomy bi-ties

Device: novel tracheostomy bi-ties

traditional tracheostomy tie

ACTIVE COMPARATOR

those with traditional tracheostomy tie

Device: traditional Tracheostomy ties

Interventions

novel tracheostomy bi-ties DEVICE

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.

novel tracheostomy bi-ties

traditional Tracheostomy ties DEVICE

Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.

traditional tracheostomy tie

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Shanxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Results Point of Contact

• Title: Dr.Jun Tian
• Organization: The First Hospital of Shanxi Medical University

zguotian@126.com

+8618612270351

Study Officials

• Binquan Wang

  The First Affiliated Hospital of Shanxi Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 30, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 31, 2019
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

CN (1)