Role of Neutrophil Activation

The Washington University

Status: Completed

Conditions: Patients Requiring Endotracheal Intubation

Treatments: Procedure: tracheal lavages

Study type: Interventional

Funder types: Other

Identifiers

NCT01815229

201301037

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 2 patient groups, including a placebo group

tracheal lavages

Experimental group

Description:

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.

Treatment:

Procedure: tracheal lavages

Healthy Control

Placebo Comparator group

Description:

To replicate activation, neutrophils were isolated from 30mL blood of healthy volunteers and cocultured with TLF from subjects with or without sore throat pain.

Treatment:

Procedure: tracheal lavages