Patients Requiring Endotracheal Intubation
Conditions
Keywords
endotracheal, intubation
Brief summary
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.
Interventions
PROCEDUREtracheal lavages
tracheal lavages obtained during endotracheal intubation.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18 to 65 2. American Society of Anesthesiologists Physical Status Classification (ASA) I and II 3. Required to have endotracheal intubation 4. Scheduled for short admission (\<23 hrs), or ambulatory orthopedic surgery (ankle, shoulder, or extremity surgery); general surgery (exploratory laparotomy, cholecystectomy, ventral or inguinal hernia repair); obstetric/gynecological surgery(total abdominal hysterectomy, bilateral salpingo-oophorectomy); urologic surgery (nephrectomy, prostatectomy), lumbar spine surgery( discectomy, one or two level lumbar fusion) procedures. 5. Estimated duration of surgery 3 to 4 hours. 6. Provide informed consent
Exclusion criteria
1. Active pulmonary disease within 5 days prior to enrollment 2. On immunosuppressive medications 3. Previous tracheal surgery 4. On azithromycin 5. Diabetes 6. Pregnancy 7. Smoking history of less than 6 weeks prior to surgery 8. Surgery or intubation within 5 days of surgery 9. Planned surgical procedure involving neck or thoracic regions 10. Active pulmonary disease 11. Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis 12. Hepatitis 13. Cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil Cell Counts in Tracheal Lavages | average of 3.2 hours of exposure to an ETT | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time in Minutes | Up to 363 minutes for intubation time | Average amount of time that participants were intubated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 18 |
| 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. | 51 |
| Total | 82 |
Baseline characteristics
| Characteristic | Tracheal Lavages No Sore Throat | Healthy Control | Tracheal Lavages Sore Throat | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 51 Participants | 13 Participants | 82 Participants |
| Age, Continuous age /years | 40.78 years | — | 40.92 years | 41.17 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 16 Participants | 2 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 29 Participants | 9 Participants | 51 Participants |
| Region of Enrollment United States | 18 participants | 51 participants | 13 participants | 82 participants |
| Sex: Female, Male Sex Female | 7 Participants | 31 Participants | 8 Participants | 46 Participants |
| Sex: Female, Male Sex Male | 11 Participants | 20 Participants | 5 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 18 | 0 / 51 |
| other Total, other adverse events | 0 / 13 | 0 / 18 | 0 / 51 |
| serious Total, serious adverse events | 0 / 13 | 0 / 18 | 0 / 51 |
Outcome results
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
Time frame: average of 3.2 hours of exposure to an ETT
Population: Blood samples were collected form healthy controls for in vitro analysis. Neutrophil data was not collected for healthy controls.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tracheal Lavages Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | IL-1β | 112.02 neutrophil/high powered field | Standard Deviation 150.53 |
| Tracheal Lavages Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | TNF-α | 61.72 neutrophil/high powered field | Standard Deviation 72.64 |
| Tracheal Lavages Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | Il-8 | 6513.22 neutrophil/high powered field | Standard Deviation 5209.84 |
| Tracheal Lavage no Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | IL-1β | 26.98 neutrophil/high powered field | Standard Deviation 59.42 |
| Tracheal Lavage no Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | TNF-α | 27.63 neutrophil/high powered field | Standard Deviation 34.99 |
| Tracheal Lavage no Sore Throat | Neutrophil Cell Counts in Tracheal Lavages | Il-8 | 1995.59 neutrophil/high powered field | Standard Deviation 2262.19 |
Comparison: Tracheal lavages (TL) were done in intubated humans to obtain cell counts.p-value: <0.05t-test, 2 sided
Secondary
Intubation Time in Minutes
Average amount of time that participants were intubated
Time frame: Up to 363 minutes for intubation time
Population: Healthy control were not intubated.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tracheal Lavages Sore Throat | Intubation Time in Minutes | 213 minutes |
| Tracheal Lavage no Sore Throat | Intubation Time in Minutes | 175 minutes |