Role of Neutrophil Activation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01815229
First received: March 18, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Patients Requiring Endotracheal Intubation
Procedure: tracheal lavages

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • identifying neutrophil surface changes [ Time Frame: 90 minutes after surgery ] [ Designated as safety issue: No ]
    Physiologic and demographic measurements such as temperature, oxygenation, and blood pressure, gender, body mass index and coexisting diseases


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients requiring endotracheal itubation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815229

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Carlos A Puyo, MD, FCCP    314-747-0259    puyoc@wustl.edu   
Principal Investigator: Carlos A Puyo, MD, FCCP         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Carlos Puyo, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01815229     History of Changes
Other Study ID Numbers: 201301037
Study First Received: March 18, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
endotracheal
intubation

ClinicalTrials.gov processed this record on October 02, 2014