Trial Outcomes & Findings for Endotracheal Tube Intracuff Pressure and Leak (NCT NCT02376179)
NCT ID: NCT02376179
Last Updated: 2019-12-11
Results Overview
Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Recruitment status
COMPLETED
Target enrollment
84 participants
Primary outcome timeframe
during time of surgery
Results posted on
2019-12-11
Participant Flow
Participant milestones
| Measure |
Cuffed ETT
Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endotracheal Tube Intracuff Pressure and Leak
Baseline characteristics by cohort
| Measure |
Cuffed ETT
n=84 Participants
Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Cuffed ETT
|
|---|---|
|
Age, Categorical
<=18 years
|
84 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
5.7 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during time of surgeryChanges in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.
Outcome measures
| Measure |
Cuffed ETT
n=84 Participants
Pediatric patients intubated with a cuffed endotracheal tube for adenotonsillectomy.
Cuffed ETT
|
|---|---|
|
Changes in the Intracuff Pressure
|
3 cmH2O
Standard Deviation 7
|
Adverse Events
Cuffed ETT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place