Role of Neutrophil Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01815229
Recruitment Status : Recruiting
First Posted : March 20, 2013
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Patients Requiring Endotracheal Intubation Procedure: tracheal lavages

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sore Throat Secondary to Endotracheal Intubation: the Role of Neutrophil Activation
Study Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. identifying neutrophil surface changes [ Time Frame: 90 minutes after surgery ]
    Physiologic and demographic measurements such as temperature, oxygenation, and blood pressure, gender, body mass index and coexisting diseases

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring endotracheal itubation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01815229

United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Carlos A Puyo, MD, FCCP    314-747-0259   
Principal Investigator: Carlos A Puyo, MD, FCCP         
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Carlos Puyo, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine Identifier: NCT01815229     History of Changes
Other Study ID Numbers: 201301037
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Washington University School of Medicine: