N/A
N=82
Role of Neutrophil Activation
Patients Requiring Endotracheal Intubation
Bottom Line
View on ClinicalTrials.gov: NCT01815229 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Neutrophil Cell Counts in Tracheal Lavages — 112.02; 26.98; 61.72; 27.63 neutrophil/high powered field — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tracheal lavages (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neutrophil Cell Counts in Tracheal Lavages |
112.02; 26.98; 61.72; 27.63; 6513.22; 1995.59 | <0.05 sig |
| SECONDARY Intubation Time in Minutes |
213; 175 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01815229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.