Concordance of Methods to Select Tracheostomy Tube Size for Adults in Intensive Care

NCT05047432 | Unknown

• 3 other identifiers: 136601272157NIHR300537
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study is part of a larger PhD project. The aim of the overall project is to provide evidence to help healthcare staff choose the best size tracheostomy breathing tube for patients in intensive care. There are no clear guidelines on how to choose the size of tracheostomy tubes currently. The aim of this part of the project is to compare methods of choosing the size tracheostomy tube for patients. Four methods are based on easily recorded physical characteristics of the participants (sex, height, Body Mass Index and shoulder width). A fifth method is based on measurement of the windpipe (trachea). We will recruit patients and staff at the Royal Free London NHS Foundation Trust. We will measure their height, weight and shoulder width, and record their age and sex. We will use ultrasound to measure each participant's trachea. We will calculate the recommended tube size using the five methods above. We will compare how well the first four methods agree with the method based on measurements of the trachea. The results of this study will inform healthcare staff how well the different ways of choosing the size of tube relate to the fit of a tube in the trachea.

Conditions

Tracheostomy

Keywords

tracheostomy; tracheotomy; trachea; biometrics

Outcome Measures

Primary Outcomes (1)

• Concordance (% agreement) between size selection methods in tracheostomy

  Concordance between 4 methods of selecting size of tracheostomy that are based on patient height, BMI, sex or shoulder width, and a method based on measurement of the trachea.

  20 months

Secondary Outcomes (1)

• Association between tracheal diameter and other patient anthropometrics/demographics

  20 months

Interventions

Non-interventional trial OTHER

Non-interventional trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult staff and patients at the Royal Free London NHS Foundation Trust hospital sites.

You may qualify if:

• Adult (aged 18 years and older) staff and patients at Royal Free London NHS Foundation Trust hospital sites (Barnet Hospital and the Royal Free Hospital).

You may not qualify if:

• Severe kyphosis of the spine
• Patients lacking capacity to consent
• Prisoners
• Pregnancy

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free London NHS Foundation Trust

London, EN5 3DJ, United Kingdom

RECRUITING

Related Publications (25)

• National Confidential Enquiry into Patient Outcome and Death (2014) On the right Trach? A review of the care of patients who underwent a tracheostomy. NCEPOD, London (https://www.ncepod.org.uk/2014report1/downloads/OnTheRightTrach_FullReport.pdf accessed 09/08/2021)

  BACKGROUND

• Comprehensive Tracheostomy Care - The NTSP Manual [Internet]. 2013 [cited 2019 Jan 19]. p. 207. Available from: http://tracheostomy.org.uk/resources

  BACKGROUND

• Bodenham, A, Bell D, Bonner S, Branch F, Dawson D, McGrath B, et al. Intensive Care Society Standards for the care of adult patients with a temporary Tracheostomy. 2014.

  BACKGROUND

• Newman H, Sutt A-L, Wallace S. 0063 Choosing the size of tracheostomy tube for adults in UK intensive care units: how do we do it? J Intensive Care Soc. 2020;21(2_suppl):37-8

  BACKGROUND

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MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Helen M Newman, MSc

  UCL Division of Surgery and Interventional Science (UK); Royal Free London NHS Foundation Trust (UK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen M Newman, MSc

CONTACT

+44 2082164600; helen.newman.20@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: November 19, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)