Role of Neutrophil Activation

NCT ID: NCT01815229

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-07-31

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.

Conditions

Patients Requiring Endotracheal Intubation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

tracheal lavages

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.

Group Type: EXPERIMENTAL

tracheal lavages

Intervention Type: PROCEDURE

tracheal lavages obtained during endotracheal intubation.

Healthy Control

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

Group Type: PLACEBO_COMPARATOR

tracheal lavages

Intervention Type: PROCEDURE

tracheal lavages obtained during endotracheal intubation.

Interventions

tracheal lavages

tracheal lavages obtained during endotracheal intubation.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Puyo, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201301037

Identifier Type: -

Identifier Source: org_study_id