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Patients will undergo placement of an endotracheal tube (ETT) as standard of care. Tracheal lavage will be conducted using 5 mL of sterile saline solution by a push/suction technique. Specimen samples obtained by wall suction will be collected at 2 time points following intubation.
Blood samples will be obtained at 2 time points, simultaneous with the collection of the tracheal specimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tracheal lavages | Experimental | 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 | Placebo Comparator | To replicate activation, neutrophils were isolated from 30mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tracheal lavages | Procedure | tracheal lavages obtained during endotracheal intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil Cell Counts in Tracheal Lavages | 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 | average of 3.2 hours of exposure to an ETT |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time in Minutes | Average amount of time that participants were intubated | Up to 363 minutes for intubation time |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Puyo, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Healthy Control | A one time blood sample of approx 30cc will be collected by venipuncture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neutrophil Cell Counts in Tracheal Lavages | 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 | Blood samples were collected form healthy controls for in vitro analysis. Neutrophil data was not collected for healthy controls. | Posted | Mean | Standard Deviation | neutrophil/high powered field | average of 3.2 hours of exposure to an ETT |
|
approximately 5 hours per participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos Puyo | Washington University School of Medicine | 314-747-1709 | cpuyo@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2016 | Jun 22, 2018 | Prot_SAP_000.pdf |
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| BG001 | 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. |
| BG002 | Healthy Control | To replicate activation, neutrophils were isolated from 20mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age collected categorically for healthy controls. Unable to calculate mean values. | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Tracheal Lavage 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. |
|
|
|
| Secondary | Intubation Time in Minutes | Average amount of time that participants were intubated | Healthy control were not intubated. | Posted | Mean | Full Range | minutes | Up to 363 minutes for intubation time |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | Healthy Control | To replicate activation, neutrophils were isolated from 20mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|