Tracheostomy Management in Critical Care: a randomised controlled trial

Oxford Radcliffe Hospitals NHS Trust (UK)0 个研究点目标入组 1,208 人开始时间: 2004年12月1日最近更新: 2020年6月22日

适应症

试验速览

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23695482 2. 2020 propensity score matched cohort study results in https://doi.org/10.1136/bmjopen-2020-037762 (added 10/06/2020)

•Eligible patients are those who
•1. Are intubated
•2. Have a high chance of requiring a further 7 days or more of ventilatory support during their ICU stay
•3. Have been in the intensive care unit for less than 4 days
•4. The recruiting consultant is uncertain about whether an 'early' or 'late' tracheostomy is more appropriate for this patient

•The uncertainty principle can also be used to determine which patients are ineligible for the trial. However ethical approval requires explicit listing of excluded patients and vulnerable groups. The following patients must not be included in the trial:
•1. Not assessed on days 1-4 following ICU admission regarding their predicted requirement for at least a further 7 days of ventilatory support.
•2. For whom an immediate tracheostomy is required to alleviate upper airway obstruction
•3. With a tracheal stoma or tracheostomy tube in situ on admission to the ICU
•4. With chronic hypercarbic (type 2) respiratory failure due to a chronic neurological disease
•5. Less than 16 years of age
•6. Previously enrolled in the TracMan trial during the same hospital admission
•7. Refusing consent or patients in whom relatives refuse assent
•8. Who were ?legally incompetent? prior to their hospital admission
•9. Or their relatives who do not understand written or verbal information for whom an interpreter is not available

发起方

Oxford Radcliffe Hospitals NHS Trust (UK)