Scoring Method for Describing the Position of a Tracheostomy Tube
Recruitment status was Not yet recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
- Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||February 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Aims & Outcomes
- Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position
- 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
- Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
- Assess correlation between the best scoring system (chosen by above) with the translaryngeal view
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356719
|Contact: Brendan A McGrath, MB ChB||+44 161 291 firstname.lastname@example.org|
|University Hospital of South Manchester||Not yet recruiting|
|Manchester, United Kingdom, M23 9LT|
|Principal Investigator:||Brendan A McGrath, MB ChB||University Hospital of South Manchester|