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

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

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 surgery

Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.

Outcome measures

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

Kris Jatana, MD

Nationwide Children's Hospital

Phone: 614-722-6032

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place