Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221377
Status:
COMPLETED
Last Update Posted:
2012-05-17
First Post:
2005-09-13
Brief Title:
Cuffed Versus Uncuffed Tracheal Tubes in Small Children
Sponsor:
University Childrens Hospital Zurich
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
Cuffed Versus Uncuffed Tracheal Tubes in Small Children
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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 15 above the baseline airway-injury rate of 25 when using uncuffed tubes with a power of 90 and a type I error probability of less than 5
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 15 above the baseline airway-injury rate of 25 when using uncuffed tubes with a power of 90 and a type I error probability of less than 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| no grants | None | None | None |