The Efficacy of an Oscillating Bed in the Prevention of Lower Respiratory Tract Infection: METHODS
This study was approved by the Committee on the Protection of Human Subjects in Research at the University of Massachusetts Medical Center. Verbal informed consent was obtained from patients or responsible third parties within 24 h of entry into the trial.
Patients were eligible for entry into the trial if they had serious nonpenetrating injuries and were likely to require care in the SICU for more than 24 h. Within 24 h of admission to the SICU, patients were randomly allocated to care using a conventional hospital bed or to care using a RRKTT (Kinetic Concepts, Inc, San Antonio, TX). The treatment group for a particular patient was determined by opening the appropriate sequentially numbered opaque envelope containing the patients group assignment. The randomization schedule was generated using a table of random numbers. We prospectively excluded patients with unstable spine injuries because we considered it unethical to use a conventional bed for patients with these problems. Retrospectively excluded were patients (n = 7) who were discharged from the SICU within 24 h of admission.
Patients were actively studied only while they were in the SICU. After discharge from the SICU, the choice of bed type was determined not by protocol, but by the patients physician. The primary outcome variables were incidence of all LRTI and incidence of pneumonia during the period the patient was being cared for in the SICU. Secondary outcome variables were LOS in the SICU, total LOS in the hospital and duration of intubation. Durations of intubation and LOS in the SICU and hospital were calculated by calendar day. Thus, for example, a patient admitted at 10:00 PM on April 3 and discharged at 11:00 AM on April 4 was scored as having been in the SICU one day.
buy antibiotics canada
Lower respiratory tract infection (ie, tracheobronchitis or pneu¬monia) was defined by the presence of all of the following within a 24-h period: fever (temperature ^38.5 °C); purulent sputum (>3 + polymorphonuclear leukocytes on the Cram-stained smear); and positive sputum culture (>2 + growth for one or more pulmonary pathogens). Note that 3+ leukocytes was defined as 6 to 30 cells per oil-immersion (1,000 x) field; 2-I- bacterial growth was defined as >=10 colonies on the primary quadrant, and no colonies on the secondary, tertiary or quaternary quadrants, of the agar plate. Pneumonia was defined using the same criteria as for LRTI with an additional requirement for roentgenographic evidence of pulmonary infiltrates that persisted for at least three days.
The ISS, an anatomic measure of the degree of trauma, was calculated based on a retrospective chart review according to the method of Baker et al and Baker and O’Neill. The APACHE II score, an index of the magnitude of physiologic derangement, was calculated based on values recorded during the first 24 h of admission to the SICU, as described by Knaus et al. Major head trauma was defined as loss of consciousness (due to trauma) for greater than 24 h. Major intrathoracic trauma was defined as significant injury to the heart or great vessels; in actuality, this term was synonymous with traumatic rupture of the thoracic aorta. Major intraabdominal trauma was defined by the presence of major lacerations or parenchymal injuries involving the liver, spleen, pancreas, gallbladder and/or other intraabdominal organs. Excluded were minor splenic and hepatic lacerations and capsular tears and minor mesenteric lacerations. Pulmonary contusion was defined by the presence of characteristic radiographic findings within 24 h of injury in the setting of significant thoracic trauma. The meaning of femur fracture is self-explanatory.
Data were analyzed on a Harris model 1000 mainframe computer using the BMDP statistical software package. Incidence data (eg, incidence of pulmonary contusion) are presented as the number of patients with that diagnosis followed (in parentheses) by the percentage of the particular study group with that diagnosis. All other numerical data are presented as median values (with the range in parentheses). Except where noted in the text, results were analyzed based on intention to treat rather than treatment actually received. Differences between groups for incidence data were assessed using Fishers exact test. All other statistical comparisons between groups were performed using the (two-tailed) Mann- Whitney U test. Risk factors for the development of LRTI were assessed using stepwise logistic regression analysis. The model was developed by including only candidate variables that resulted in a significant improvement in fit as measured by the improvement chi-square statistic.
kamagra oral jelly uk
