Role of Neutrophil Activation

Study Overview
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Brief Summary
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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.

Official Title
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Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation

Conditions
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Patients Requiring Endotracheal Intubation

Intervention / Treatment
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* Procedure: tracheal lavages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Ages 18 to 65 American Society of Anesthesiologists Physical Status Classification (ASA) I and II Required to have endotracheal intubation 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. Estimated duration of surgery 3 to 4 hours. Provide informed consent Exclusion Criteria Active pulmonary disease within 5 days prior to enrollment On immunosuppressive medications Previous tracheal surgery On azithromycin Diabetes Pregnancy Smoking history of less than 6 weeks prior to surgery Surgery or intubation within 5 days of surgery Planned surgical procedure involving neck or thoracic regions Active pulmonary disease Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis Hepatitis Cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tracheal lavages<br>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. | Procedure: tracheal lavages<br>* tracheal lavages obtained during endotracheal intubation.<br>|
| Placebo Comparator: Healthy Control<br>To replicate activation, neutrophils were isolated from 30mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain. | Procedure: tracheal lavages<br>* tracheal lavages obtained during endotracheal intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time in Minutes | Average amount of time that participants were intubated | Up to 363 minutes for intubation time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endotracheal, intubation