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Scoring Method for Describing the Position of a Tracheostomy Tube

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Hospital of South Manchester NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01356719
First received: May 16, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition
Tracheostomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Further study details as provided by University Hospital of South Manchester NHS Foundation Trust:

Primary Outcome Measures:
  • Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determine the scoring system with the best inter-rater agreement as defined by weighted kappa and intra-class correlation coefficients.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356719

Contacts
Contact: Brendan A McGrath, MB ChB +44 161 291 6420 drbamcgrath@gmail.com

Locations
United Kingdom
University Hospital of South Manchester Not yet recruiting
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
University Hospital of South Manchester NHS Foundation Trust
Investigators
Principal Investigator: Brendan A McGrath, MB ChB University Hospital of South Manchester
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Brendan McGrath, University Hospital of South Manchester, Southmoor Rd, Wythenshawe, Manchester. M23 9LT
ClinicalTrials.gov Identifier: NCT01356719     History of Changes
Other Study ID Numbers: LUNAR2011
Study First Received: May 16, 2011
Last Updated: May 18, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospital of South Manchester NHS Foundation Trust:
Tracheostomy
adverse effects
Critical Care
standards
safety

ClinicalTrials.gov processed this record on November 20, 2014