Scoring Method for Describing the Position of a Tracheostomy Tube

Tracheostomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356719
• Other study ID #: LUNAR2011
• Status: Completed
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2020
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tracheostomy

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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