Scoring Method for Describing the Position of a Tracheostomy Tube

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Tracheostomy

Clinical Trial Details

NCT number	NCT01356719
Study type	Observational
Source	Manchester University NHS Foundation Trust
Contact
Status	Completed
Phase
Start date	July 2011
Completion date	February 2012

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.