Library

Notes: Abstract We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750–1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of brith (median time of treatment 6.2 h, range 3.2–9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P〈0.0001), and larger average decreases in FiO2 (P〈0.0001) and mean airway pressure, (MAP) (P〈0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE=0.03) for a/A ratio, −0.28 (SE=0.04) for FiO2 and −1.7 cm H2O (SE=0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants. There were no significant differences between the groups with respect to the incidence of patent ductus arteriosus, bronchopulmonary dysplasia, necrotizing entero-colitis, air leaks or death. There was a statistically significant difference between treated and control infants in the frequency and severity of periventricular-intraventricular hemorrhage (PIH) (Cochran-Mantel-Haenszelχ 2adj=6.36,P=0.01). Hemorrhages occurred in 59.6% of surfactant treated infants and 26.9% of controls. Severe hemorrhages (grades 3 or 4) occurred in 38.5% of surfactant treated infants and 15.4% of controls (χ 2adj=4.01,P=0.045). We conclude that the intratracheal administration of Survanta prior to 8 h of age to infants with IRDS receiving assisted ventilation with 40% or more oxygen results in a reduction in the severity of respiratory distress during the 48 h after therapy. Because of the difference in incidence of PIH between surfactant and control infants in this study, we recommend that future clinical trials of surfactant include more frequent prospective serial ultrasound evaluations for diagnosis of hemorrhage.

Notes: Abstract In a prospective randomized study using a canine model, we compared the use of monopolar electrosurgery (EC) (n=23) and the Nd:YAG Contact Laser™ (CL) (n=21) on intra- and postoperative morbidity in laparoscopic large-bowel resection. In EC, cutting was performed with scissors and coagulation was performed with electrosurgery. In CL, cutting and coagulation were carried out with the Nd:YAG Contact Laser™. Laparoscopic oncologic right colectomy with intraperitoneal ileocolic stapled anastomosis was performed in all dogs. Intraoperative smoke development, difficulty of dissection, hemostasis, and postoperative adhesions were judged using a five-point score. Two weeks after surgery, all dogs were sacrificed and zoopsy was carried out. Three dogs died postoperatively from pneumonia and one from an anastomotic leak. There were no other postoperative complications. Operative time was 135 min (range 105–180) in the CL group and 145 min (range 60–210) in the EC group. Intraoperative smoke development, difficulty of dissection, and postoperative amount of adhesions were not different between groups (P〉0.05). Hemostasis in the CL group (median score of 1, range 1–2) was significantly better (P=0.01) than in the EC group (median score of 2, range 1–5). Scissors and electrosurgery as well as Nd:YAG Contact Laser™ can be used successfully in intestinal laparoscopic surgery. Although the use of the Contact Laser™ did not cause less postoperative morbidity than the conventional method, there was significantly better hemostasis using the Nd:YAG Contact Laser™.