Trial Outcomes & Findings for Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures. (NCT NCT01738321)
NCT ID: NCT01738321
Last Updated: 2017-03-21
Results Overview
Recruitment status
COMPLETED
Target enrollment
63 participants
Primary outcome timeframe
1 day
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
Cardiac Patients
Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
Non-cardiac Patients
Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
33
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Changes in Intracuff Pressure of a Cuffed Endotracheal Tube During Prolonged Surgical Procedures.
Baseline characteristics by cohort
| Measure |
Cardiac Patients
n=33 Participants
Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
Non-cardiac Patients
n=30 Participants
Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
2.8 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
9.9 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
8.2 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
30 participants
n=107 Participants
|
63 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 dayOutcome measures
| Measure |
Cardiac Patients
n=33 Participants
Patients undergoing cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
Non-cardiac Patients
n=30 Participants
Patients undergoing any surgery other than cardiac surgery
Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure
|
|---|---|---|
|
Change in Intracuff Pressure
|
-11.8 cmH2O
Standard Deviation 6.4
|
-9.5 cmH2O
Standard Deviation 29.7
|
Adverse Events
Cardiac Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-cardiac Patients
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