NCT01356719

Scoring Method for Describing the Position of a Tracheostomy Tube

LUNAR Study - Develop and Validate a Bedside Scoring Method for Describing the Position and Orientation of a Tracheostomy Tube Tip When Viewed Endoscopically From a Standardised Position

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Tracheostomies are artificial airway devices inserted into the neck. They can become displaced and lead to patient harm. Other than external visual inspection, there is no currently described system for describing the position of a tracheostomy tube within the airway. The investigators propose to undertake endoscopic inspection of the tracheostomy tube with a small fibre-optic camera from above and also through the tube to visualise its position within the airway. The investigators will take anonymised paired images and then score these using 6 different scoring systems. The investigators will determine which scoring system provides the simplest and most reproducible scores between 6 blinded assessors. A clinically useful scoring system could be used in future to predict problems with tracheostomy positioning.

Detailed description

Aims \& Outcomes 1. Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position 2. Secondary aims * Correlate the endoscopic views of the tracheostomy tube with the trans-laryngeal views. * Is it possible to predict the trans-laryngeal view from the endoscopic view. * Does the position of a tracheostomy tube tip change when the patient is repositioned following percutaneous tracheostomy (when viewed endoscopically) * Equipment training: Compare the number of supervised endoscopies required to consistently achieve the required standardised view 3. Primary outcome \- Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients. 4. Secondary outcome \- Assess correlation between the best scoring system (chosen by above) with the translaryngeal view 5. Tertiary aim - Assessment of training: Determine the number of attempts required to obtain adequate standardised views. This will be a manikin based assessment to demonstrate competence in performing the endoscopies for the study before any procedures are undertaken on patients.

Conditions

• Tracheostomy

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2011-05-19
• Last updated: 2020-06-01

Locations

1 site across 1 country: United Kingdom