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
1 other identifier
observational
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedJune 1, 2020
May 1, 2020
4 months
May 16, 2011
May 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
6 months
Eligibility Criteria
Adults (\>16yrs) who have a tracheostomy performed as part of their intensive care management
You may qualify if:
- Adults \>16 years old
- Presence of a percutaneous or surgical tracheostomy
- Patient being cared for in the AICU of UHSM
You may not qualify if:
- Endoscopy not clinically appropriate (in the opinion of the attending physician)
- Refusal by patient or their representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of South Manchester
Manchester, M23 9LT, United Kingdom
Related Publications (1)
McGrath BA, Lynch K, Templeton R, Webster K, Simpson W, Alexander P, Columb MO. Assessment of scoring systems to describe the position of tracheostomy tubes within the airway - the lunar study. Br J Anaesth. 2017 Jan;118(1):132-138. doi: 10.1093/bja/aew336.
PMID: 28039250DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Brendan A McGrath, MB ChB
University Hospital of South Manchester
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 19, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2011
Study Completion
February 1, 2012
Last Updated
June 1, 2020
Record last verified: 2020-05