title: i-gel™ supraglottic airway in clinical practice: a prospective observational multicentre study.
abstract: BACKGROUND
  The i-gel™ supraglottic airway device has been studied in randomized controlled studies, but it has not been evaluated in a large prospective patient cohort. Therefore, we performed this prospective multicentre observational study to evaluate success rates, airway leak pressure, risk factors for i-gel failure, and adverse events.
  
  
  METHODS
  With Ethics Committee approval and waiver of patients' consent, data about anaesthesia providers, patient characteristics, and the performance of the i-gel were recorded in five independent hospitals in Switzerland over a period of 24 months. We analysed success rates, leak pressures, adverse events, and risk factors for failure.
  
  
  RESULTS
  Data from 2049 i-gel uses were analysed. Patients' mean age was 47 (range 6-91) yr. The primary i-gel success rate without changing size was 93%; the overall success rate was 96%. Insertion was deemed very easy or easy in 92%. The mean airway leak pressure was 26 (8) cm H(2)O. The mean anaesthesia time was 67 (42) min. Risk factors associated with i-gel failure were males (P<0.001), impaired mandibular subluxation (P=0.01), poor dentition (P=0.02), and older age (P<0.01). Adverse events recorded were laryngeal spasms (n=25, 1.2%), blood stained airway devices (n=79, 3.9%), transient nerve damage (n=2, 0.1%), one case of transient vasovagal asystole, and one glottic haematoma.
  
  
  CONCLUSIONS
  The i-gel is a reliable supraglottic airway device failing in <5% and providing high airway leak pressures. Males, impaired mandibular subluxation, poor dentition, and older age are risk factors associated with primary device failure. Serious adverse events are rare.
authors.affiliation: Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami Miller School of Medicine, Gautier Bldg, Room 415, 1011 N.W. 15th Street, Miami, FL 33136, USA. lorenz.theiler@insel.ch
authors.forename: L
authors.initials: L
authors.lastname: Theiler
authors.forename: M
authors.initials: M
authors.lastname: Gutzmann
authors.forename: M
authors.initials: M
authors.lastname: Kleine-Brueggeney
authors.forename: N
authors.initials: N
authors.lastname: Urwyler
authors.forename: B
authors.initials: B
authors.lastname: Kaempfen
authors.forename: R
authors.initials: R
authors.lastname: Greif
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D004209:Disposable Equipment; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D012737:Sex Factors; D013557:Switzerland; D055815:Young Adult