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OpenTrials
Completed

NCT Number: NCT01815229

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.

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Key information

Conditions

Patients Requiring Endotracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 to 65
  • American Society of Anesthesiologists Physical Status Classification (ASA) I and II
  • Required to have endotracheal intubation
  • 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.
  • Estimated duration of surgery 3 to 4 hours.
  • Provide informed consent

Exclusion criteria

  • Active pulmonary disease within 5 days prior to enrollment
  • On immunosuppressive medications
  • Previous tracheal surgery
  • On azithromycin
  • Diabetes
  • Pregnancy
  • Smoking history of less than 6 weeks prior to surgery
  • Surgery or intubation within 5 days of surgery
  • Planned surgical procedure involving neck or thoracic regions
  • Active pulmonary disease
  • Autoimmune disease (HIV, AIDS, Rheumatoid Arthritis
  • Hepatitis
  • Cancer

Treatment and study plan

tracheal lavages

Procedure

tracheal lavages obtained during endotracheal intubation.

Primary outcomes

  1. Neutrophil Cell Counts in Tracheal Lavages

    Time frame: average of 3.2 hours of exposure to an ETT

    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

Secondary outcomes

  1. Intubation Time in Minutes

    Time frame: Up to 363 minutes for intubation time

    Average amount of time that participants were intubated

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2013
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.