SummaryFatal oesophageal perforation occurred as a complication of elective general anaesthesia for cataract extraction in a 77-year-old female patient. Tracheal intubation had been achieved, albeit with difficulty, in the course of a clinical trial of the intubating laryngeal mask.Keywords Equipment; intubating laryngeal mask. Complications. ...................................................................................... Correspondence to: Dr M. A. Branthwaite Accepted: 30 May 1998 The laryngeal mask has found a useful place in anaesthetic practice both within and outside the hospital environment. A modified system, the intubating laryngeal mask, has been introduced recently to facilitate endotracheal intubation and a fatality resulting from its use is reported here.
Case historyA 77-year-old female patient, ASA II, was scheduled for elective cataract extraction under general anaesthesia. Contralateral cataract extraction had been carried out uneventfully 8 months earlier under general anaesthesia involving controlled ventilation delivered through a size 4 laryngeal mask.On the evening before surgery, the patient consented orally to participate in a proposed trial of the intubating laryngeal mask. She received no written information about the trial and a designated consent form for participation was neither offered nor signed. A protocol for trial of a prototype intubating laryngeal mask had been cleared by the hospital Ethics Committee 3 years previously but had been deferred pending inclusion of the hospital in a multicentre trial of the definitive model. A draft protocol for the multicentre trial differed in a number of respects, most notably that it permitted a maximum of five attempts at intubation instead of two as proposed initially. The revised protocol had not been submitted to the local Ethics Committee.On the day of surgery, the patient was one of several on whom the technique of intubation through the definitive model of the intubating laryngeal mask was demonstrated. Difficulty was encountered in intubation, the mask was replaced at least once and intubation was only achieved successfully on the fifth attempt. Oesophageal intubation was suspected on the unsuccessful attempts. Blood was aspirated from the pharynx after intubation and a nasogastric tube, passed without difficulty to decompress the stomach, confirmed the presence of bleeding.Once awake, the patient complained of pain in the back and crepitus was noted in the neck. A chest X-ray about 3 h postoperatively showed air in the soft tissues and both sides of the mediastinum. There was a small effusion at the right base and some plate atelectasis at the left base. Oesophageal rupture was confirmed radiologically using a dilute solution of barium. The report described a fairly large oesophageal pouch arising from the posterior wall with a small amount of barium passing through a fistulous opening situated just below the neck of the pouch.A policy of conservative management was adopted but the patient's condition gave rise to increas...