Role of Neutrophil Activation

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

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.

Study Overview

• Status: Completed
• Conditions: Patients Requiring Endotracheal Intubation
• Intervention / Treatment: Procedure: tracheal lavages

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: tracheal lavages; tracheal lavages obtained during endotracheal intubation.
Placebo Comparator: 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.	Procedure: tracheal lavages; tracheal lavages obtained during endotracheal intubation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Carlos Puyo, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 18, 2013
• First Posted (Estimate): March 20, 2013

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: intubation; endotracheal
• Other Study ID Numbers: 201301037