[Clinical use of the ProSeal™ laryngeal mask in infants, children and adolescents : prospective observational survey].

BACKGROUND: In contrast to the adult population scientific data on ProSeal™-LMA (PLMA) usage in infants, children, and adolescents are rather limited. Most data have been generated by expert users in studies on small numbers of patients. The aim of this study was to gather comprehensive data about the characteristics, efficacy and safety of its routine use in children at a teaching institution.
METHODS: Using a standardized reporting form the following data were collected in the course of a prospective survey on PLMA usage in patients aged up to 18 years: user characteristics, patient characteristics, type and duration of operation, details of airway management and anesthetic technique, details of PLMA usage-related critical incidents and postoperative status of the patient.
RESULTS: Use of the PLMA was documented in 512 patients by 61 anesthesiologists (32% staff grade, 68% trainees). The average age, height and weight of the patients was 8 years (range 0-17 years), 130 cm (range 54-193 cm) and 29 kgBW (range 5-130 kgBW), respectively. Anesthesia was induced intravenously in 458 patients (89.5%) and by inhalation in 54 patients. Maintenance of anesthesia was by total intravenous anesthesia (propofol) in 184 patients (36.5%) and by an inhalational agent (sevoflurane or desflurane) in 320 patients (63.7%). Neuromuscular blocking agents were used in 7 patients (1.4%). The patients were anesthetized for an average of 80 min (range 15-270 min) and insertion success rate was 99% with a maximum of 3 attempts. The average initial airway leak pressure was 27cm H(2)O (range 12-40 cm H(2)O); however, lower pressures were recorded for smaller size masks (size 1.5-2.5) without a dorsal cuff than for larger size masks (size 3-5; p<0.01). Ventilation was controlled in 96% and combined with PEEP in 39% of cases. Critical incidents associated with PLMA were documented in a total of 8.4% of cases, the majority being minor trauma, evidenced by blood on the PLMA on removal, followed by some form of airway obstruction. In 3.3% of cases these incidents were judged as clinically relevant of which 0.6% were classified as serious. Twice as many problems occurred during induction of anesthesia as in the maintenance phase and emergence phase of anesthesia (p=0.037). In 1.6% the PLMA was abandoned in favor of the endotracheal tube. In 7 patients the PLMA was exchanged in the induction room whereas in 1 patient this took place intraoperatively. Failure of ProSeal™ laryngeal mask use correlated with the level of PLMA use experience with 75% of failures caused by users with an experience of less than 50 uses and no failure in users with an experience of more than 100 uses. Failure did not correlate with the size of the mask. In 2 cases the PLMA was successfully used after failed endotracheal intubation. In 6 patients drainage of regurgitated gastric fluid through the drain tube was documented. No long-term adverse sequelae resulted in any patient.
CONCLUSION: This survey demonstrates that the PLMA can be used effectively in infants, children and adolescents in the routine university clinical practice setting. However, this study does not confirm the extremely high success and low complication rates reported in controlled studies. The results support the assumption that with the PLMA regurgitated gastric fluid can be drained away from the larynx through the drain tube.