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OpenTrials
Completed

NCT Number: NCT01356719

Scoring Method for Describing the Position of a Tracheostomy Tube

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.

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Key information

Conditions

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

About this study

Aims & Outcomes

  • Develop an appropriate bedside scoring method for describing the position and orientation of a tracheostomy tube tip when viewed endoscopically from a standardised position
  • 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
  • Primary outcome
  • Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.
  • Secondary outcome
  • Assess correlation between the best scoring system (chosen by above) with the translaryngeal view
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.

    Time frame: 6 months

    Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 19, 2011
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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