Clinical trial NCT01356719: Scoring Method for Describing the Position of a Tracheostomy Tube
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy
Keywords: Tracheostomy
adverse effects
Critical Care
standards
safety
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2011-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\>16yrs) who have a tracheostomy performed as part of their intensive care management

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
affiliation: University Hospital of South Manchester
name: Brendan A McGrath, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.