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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01356719

Enrollment

Registered

2011-05-19

Start date

2011-07-31

Completion date

2012-02-29

Last updated

2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomy

Keywords

Tracheostomy, adverse effects, Critical Care, standards, safety

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.	6 months	Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.

Countries

United Kingdom

Outcome results