Influence of long-term oro- or nasotracheal intubation on nosocomial maxillary sinusitis and pneumonia: results of a prospective, randomized, clinical trial.

OBJECTIVE: To compare the occurrence rate of nosocomial maxillary sinusitis and pneumonia in patients who have undergone nasotracheal vs. orotracheal intubation.
DESIGN: Randomized, clinical trial.
SETTING: General adult intensive care unit (ICU) in a nonteaching public hospital. PATIENTS: A total of 300 (209 male, 91 female) patients were included. The mean age was 59 +/- 17 (SD) yrs. The simplified acute physiologic score was 14 +/- 6. Reasons for admission to the ICU were: coma (n = 78), pneumonia (n = 46), infection (n = 35), surgery (n = 34), multiple trauma (n = 20), head trauma (n = 12), other (n = 75). Among the 300 patients, 149 were randomized into the nasotracheal group and 151 into the orotracheal group. No statistical difference was found between initial characteristics of the two groups.
INTERVENTIONS: Patients were randomized between nasal and oral endotracheal intubation. Gastric intubation was performed via the same route as endotracheal intubation. Sinus computed tomography (CT) scans were performed every 7 days or earlier in case of fever and/or purulent nasal discharge. Criteria for nosocomial sinusitis were as follows: fever of > 38 degrees C, radiographic (sinusal air-fluid level or opacification on CT scan) signs and presence of purulent aspirate from the involved sinus puncture with 10(3) colony-forming units (cfu)/mL. Diagnosis of pneumonia was based on classical criteria and a protected brush specimen with 10(3) cfu/mL.
MEASUREMENTS AND MAIN RESULTS: Radiographic evidence of sinusitis was observed in 78 patients, 45 from the nasal group and 33 from the oral group (p = .08, log-rank test). Among these patients, 54 fulfilled the sinusitis criteria stated above, 29 in the nasal group and 25 in the oral group (p = .75, log-rank test). Nosocomial pneumonia was observed in 26 patients, 17 in the nasal group and 9 in the oral group (p = .11, log-rank test). A multivariable analysis considering sinusitis as a time-dependent factor has suggested that sinusitis increased the risk of nosocomial pneumonia by a factor of 3.8. Nosocomial septicemia was observed in 33 patients, 22 episodes in the nasal group and 13 episodes in the oral group (p = .11, log-rank test). Overall mortality rate was 37% in the nasal group vs. 41% in the oral group (p = .37, log-rank test). Episodes of atelectasis and accidental extubations, and doses of sedative drugs and antibiotics were not different between the two groups. Length of mechanical ventilation did not differ between the two intubation groups. The mean length of stay in the ICU was 11 +/- 15 days in the nasal group vs. 9.5 +/- 11 days in the oral group (p = .27, Student's t-test).
CONCLUSIONS: In patients undergoing prolonged mechanical ventilation, there was no statistically significant difference in the occurrence rate of nosocomial sinusitis or pneumonia between patients undergoing tracheal intubation via the nasal vs. oral route. A trend (p = 0.008) suggests less sinusitis in the orotracheal group.

RCT Entities:   Population Interventions Outcomes