Trial Outcomes & Findings for The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery (NCT NCT01539135)
NCT ID: NCT01539135
Last Updated: 2015-08-13
Results Overview
Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Duration of surgical procedure - from 2 to 12 hours
Results posted on
2015-08-13
Participant Flow
Participant milestones
| Measure |
Hi-Lo Endotracheal Tube
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
37
|
|
Overall Study
COMPLETED
|
43
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
Baseline characteristics by cohort
| Measure |
Hi-Lo Endotracheal Tube
n=43 Participants
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
n=37 Participants
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
56 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
37 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of surgical procedure - from 2 to 12 hoursBlue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.
Outcome measures
| Measure |
Hi-Lo Endotracheal Tube
n=43 Participants
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
n=37 Participants
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
|---|---|---|
|
Number of Participants With Dye Leakage
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Time from discharge from PACU to discharge from hospital up to 72 hoursTime of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.
Outcome measures
| Measure |
Hi-Lo Endotracheal Tube
n=43 Participants
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
n=37 Participants
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
|---|---|---|
|
Length of Hospital Stay
|
42.4 hours
Standard Deviation 19.6
|
34.9 hours
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Up to 30 days after surgeryDiagnosis of postoperative pneumonia during the 30 day follow up period after surgery
Outcome measures
| Measure |
Hi-Lo Endotracheal Tube
n=43 Participants
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
n=37 Participants
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
|---|---|---|
|
Number of Participants With Postoperative Pneumonia
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Time from discharge from PACU to discharge from hospital up to 72 hoursIncidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.
Outcome measures
| Measure |
Hi-Lo Endotracheal Tube
n=43 Participants
Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
TaperGuard Endotracheal Tube
n=37 Participants
TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
|
|---|---|---|
|
Number of Participants With Unanticipated Intensive Care Unit Admission
|
3 participants
|
3 participants
|
Adverse Events
Hi-Lo Endotracheal Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TaperGuard Endotracheal Tube
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