Role of Neutrophil Activation

Patients Requiring Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815229
• Other study ID #: 201301037
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2017

Study information

• Verified date: May 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients Requiring Endotracheal Intubation

Intervention

Procedure:
• tracheal lavages
tracheal lavages obtained during endotracheal intubation.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	average of 3.2 hours of exposure to an ETT
Secondary	Intubation Time in Minutes	Average amount of time that participants were intubated	Up to 363 minutes for intubation time