NCT02820181

Assessment of a Novel Tracheostomy Tie

Assessment of Functionality and Performance of a Novel Tracheostomy Tie

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The First Affiliated Hospital of Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DEVICE	traditional Tracheostomy ties	Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-05-01
• Completion: 2019-05-31
• First posted: 2016-06-30
• Last updated: 2021-11-02
• Results posted: 2021-11-02

Locations

1 site across 1 country: China