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临床试验/NCT05047432
NCT05047432Unknown不适用

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

University College, London1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年11月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
114
试验地点
1
主要终点
Concordance (% agreement) between size selection methods in tracheostomy

研究概览

简要总结

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.

详细描述

  1. INTRODUCTION This piece of research constitutes one of four workstreams in an NIHR funded PhD programme of work. The overall aims of the PhD project are 1) to create guidance for Health Care Professionals (HCPs) on how to select the right size tracheostomy tube (TT) for patients in an intensive care unit (ICU), and 2) to identify ways to best ensure that HCPs follow the guidance.

This protocol is for Workstream 2. In this workstream we will calculate tube size recommendations for each participant using five methods:

  • four using sets of criteria that replicate current practice and relate to physical characteristics (sex, shoulder width, height and Body Mass Index)
  • a recommended set of criteria based on measurements of tracheal width

We will then calculate concordance (%) between tube size recommendations based on tracheal measurements and those based on other physical characteristics. Secondary analysis will determine strength of correlation between tracheal diameter and height, shoulder width, age, sex, Body Mass Index and ethnicity. The findings will provide evidence for clinicians on how the fit of a tracheostomy tube within the trachea may be affected by the size-selection criteria used.

This study in isolation is not intended to provide definitive clinical recommendations regarding the selection of tracheostomy tube size, since this also requires knowledge of 1) the impact of tube size on airflow through and around tracheostomy tubes and 2) what is important to patients in terms of functional effects of size of tube. These two issues are the focus of other workstreams within the larger programme of work. 2. BACKGROUND AND RATIONALE

Tracheostomy tubes (TT) are breathing tubes that are surgically inserted through the front of the neck. They can:

  • allow easier breathing for patients with upper airway obstruction
  • provide access to the lungs to clear secretions
  • facilitate longer term use of artificial breathing machines (mechanical ventilation, MV) by replacing breathing tubes that go through the mouth
  • help patients to be liberated from MV There are an estimated 12,000 tracheostomy insertions a year in England and the majority of these occur in intensive care units (ICUs). There are a number of widely used reference guidelines addressing the general management of patients with a TT. These state that a clinician should consider the size of the TT prior to insertion, but do not fully describe how to select the correct size. In practice, methods of selecting tracheostomy tube vary widely and decisions are often made on the basis of a patient's sex or perceived size.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

结局指标

主要结局

Concordance (% agreement) between size selection methods in tracheostomy

时间窗: 20 months

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.

次要结局

  • Association between tracheal diameter and other patient anthropometrics/demographics(20 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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