Need for Tracheal Tube Exchange Clinical Trial
Official title:
"Cuffed Versus Uncuffed Tracheal Tubes in Small Children"
This randomized controlled multi-centre trial in children from birth up to < 5 years of age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury (stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high volume - low pressure cuff combined with a cuff pressure release valve.
The use of cuffed tracheal tubes is a controversial topic in paediatric anaesthesia and
intensive care medicine. Cuffed tubes have traditionally been recommended for children older
than 8 to 10 years. During the past decade, however, several authors have argued for the use
of cuffed tracheal tubes in younger children and infants. A frequently cited argument
against their use is the fear from post-extubation morbidity, allegedly caused by cuff
induced tracheal and laryngeal airway injury. Using modern improved designed cuffed tracheal
tubes, data from randomised prospective studies, performed in paediatric anaesthesia and
intensive care units, suggest that using cuffed tracheal tubes do not carry an increased
risk for airway morbidity as compared to uncuffed tracheal tubes in children below 8 years
of age if correctly used. However, all these studies are based on single-centre experiences
and/or included only a few neonates, infants and small children. Hence, there is equipoise
as to the question, whether cuffed tubes are preferable over uncuffed standard tubes.
So, this randomized controlled multi-centre trial in children from birth up to < 5 years of
age aims to demonstrate equivalence as to the major outcome of post-extubation airway injury
(stridor) comparing uncuffed tracheal tubes to current tracheal tubes with modern high
volume - low pressure cuff combined with a cuff pressure release valve.
The primary hypothesis relates to the main outcome criteria of this study, which is
post-extubation morbidity as measured by the presence or absence of stridor after tracheal
extubation. The null-hypothesis Ho is defined as no difference in the incidence rates of
post-extubation morbidity between cuffed and uncuffed groups. The null-hypothesis (Ho:
u-Diff = 0) will be compared with the alternative hypothesis (H1: u-Diff <> 0). The study is
designed to detect a clinically unacceptable deterioration of 1.5% above the baseline
airway-injury rate of 2.5% when using uncuffed tubes with a power of 90% and a type I error
probability of less than 5%.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment