Assessment of a Novel Tracheostomy Tie

NCT ID: NCT02820181

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2019-05-31

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.

Conditions

Tracheostomy Complication

Keywords

tracheostomy ties

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

novel tracheostomy bi-ties

those with the novel tracheostomy bi-ties

Group Type: EXPERIMENTAL

novel tracheostomy bi-ties

Intervention Type: 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.

traditional tracheostomy tie

those with traditional tracheostomy tie

Group Type: ACTIVE_COMPARATOR

traditional Tracheostomy ties

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

traditional Tracheostomy ties

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jun Tian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Binquan Wang

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Shanxi Medical University

Locations

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FirstTianjunENT

Identifier Type: -

Identifier Source: org_study_id