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

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 Overview

• Status: Completed
• Conditions: Tracheostomy

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • University Hospital of South Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults (>16yrs) who have a tracheostomy performed as part of their intensive care management

Description

Inclusion Criteria:

• Adults >16 years old
• Presence of a percutaneous or surgical tracheostomy
• Patient being cared for in the AICU of UHSM

Exclusion Criteria:

• Endoscopy not clinically appropriate (in the opinion of the attending physician)
• Refusal by patient or their representative

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Principal Investigator: Brendan A McGrath, MB ChB, University Hospital of South Manchester

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (ESTIMATE): May 19, 2011

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: safety; Tracheostomy; adverse effects; Critical Care; standards
• Other Study ID Numbers: LUNAR2011