Assessment of a Novel Tracheostomy Tie (AONTT)

Assessment of Functionality and Performance of a Novel Tracheostomy Tie

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy Complication
• Intervention / Treatment: Device: novel tracheostomy bi-ties; Device: traditional Tracheostomy ties

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • The First Affiliated Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: novel tracheostomy bi-ties; those with the novel tracheostomy bi-ties	Device: novel tracheostomy bi-ties; 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.
Active Comparator: traditional tracheostomy tie; those with traditional tracheostomy tie	Device: traditional Tracheostomy ties; Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Shanxi Medical University
• Investigators: Study Director: Binquan Wang, The First Affiliated Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: tracheostomy ties
• Other Study ID Numbers: FirstTianjunENT