Trial Outcomes & Findings for Role of Neutrophil Activation (NCT NCT01815229)
NCT ID: NCT01815229
Last Updated: 2019-07-15
Results Overview
Neutrophil cell count were collected after an average of 3.2 hours of exposure to an ETT. Cell counts were performed using 10x6 per ml
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
average of 3.2 hours of exposure to an ETT
Results posted on
2019-07-15
Participant Flow
Participant milestones
| Measure |
Tracheal Lavages Sore Throat
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
Tracheal Lavages No Sore Throat
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
Healthy Control
A one time blood sample of approx 30cc will be collected by venipuncture.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
18
|
51
|
|
Overall Study
COMPLETED
|
13
|
18
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
51
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age collected categorically for healthy controls. Unable to calculate mean values.
Baseline characteristics by cohort
| Measure |
Tracheal Lavages Sore Throat
n=13 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
Tracheal Lavages No Sore Throat
n=18 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
|
Healthy Control
n=51 Participants
To replicate activation, neutrophils were isolated from 20mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
18 Participants
n=18 Participants
|
51 Participants
n=51 Participants
|
82 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=82 Participants
|
|
Age, Continuous
age /years
|
40.92 years
n=13 Participants • Age collected categorically for healthy controls. Unable to calculate mean values.
|
40.78 years
n=18 Participants • Age collected categorically for healthy controls. Unable to calculate mean values.
|
—
|
41.17 years
n=31 Participants • Age collected categorically for healthy controls. Unable to calculate mean values.
|
|
Sex: Female, Male
Sex · Female
|
8 Participants
n=13 Participants
|
7 Participants
n=18 Participants
|
31 Participants
n=51 Participants
|
46 Participants
n=82 Participants
|
|
Sex: Female, Male
Sex · Male
|
5 Participants
n=13 Participants
|
11 Participants
n=18 Participants
|
20 Participants
n=51 Participants
|
36 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
6 Participants
n=51 Participants
|
6 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
5 Participants
n=18 Participants
|
16 Participants
n=51 Participants
|
23 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=13 Participants
|
13 Participants
n=18 Participants
|
29 Participants
n=51 Participants
|
51 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=82 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
18 participants
n=18 Participants
|
51 participants
n=51 Participants
|
82 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: average of 3.2 hours of exposure to an ETTPopulation: Blood samples were collected form healthy controls for in vitro analysis. Neutrophil data was not collected for healthy controls.
Neutrophil cell count were collected after an average of 3.2 hours of exposure to an ETT. Cell counts were performed using 10x6 per ml
Outcome measures
| Measure |
Tracheal Lavages Sore Throat
n=13 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
Tracheal Lavage no Sore Throat
n=18 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
|---|---|---|
|
Neutrophil Cell Counts in Tracheal Lavages
IL-1β
|
112.02 neutrophil/high powered field
Standard Deviation 150.53
|
26.98 neutrophil/high powered field
Standard Deviation 59.42
|
|
Neutrophil Cell Counts in Tracheal Lavages
TNF-α
|
61.72 neutrophil/high powered field
Standard Deviation 72.64
|
27.63 neutrophil/high powered field
Standard Deviation 34.99
|
|
Neutrophil Cell Counts in Tracheal Lavages
Il-8
|
6513.22 neutrophil/high powered field
Standard Deviation 5209.84
|
1995.59 neutrophil/high powered field
Standard Deviation 2262.19
|
SECONDARY outcome
Timeframe: Up to 363 minutes for intubation timePopulation: Healthy control were not intubated.
Average amount of time that participants were intubated
Outcome measures
| Measure |
Tracheal Lavages Sore Throat
n=13 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
Tracheal Lavage no Sore Throat
n=18 Participants
After the placement of the endotracheal tube (Hi-Lo™ Evac Mallinckrodt), tracheal lavages will be performed.
A simultaneous blood sample of approx 5cc, will be collected by venipuncture or by sampling from intravenous or arterial line if available. The same procedure for collection of tracheal sample and blood will be repeated at the end of the surgical procedure and immediately prior to removal of the ETT. A total of approx 10cc blood will be collected for research purposes.
tracheal lavages: tracheal lavages obtained during endotracheal intubation.
|
|---|---|---|
|
Intubation Time in Minutes
|
213 minutes
Interval 123.0 to 354.0
|
175 minutes
Interval 55.0 to 363.0
|
Adverse Events
Tracheal Lavages Sore Throat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tracheal Lavages No Sore Throat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control
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
Dr. Carlos Puyo
Washington University School of Medicine
Phone: 314-747-1709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place