title: Efficacy of a new device to optimize positive pressure ventilation via face mask in edentulous patients: a randomized trial.
abstract: BACKGROUND
  Mask ventilation is routinely performed during anesthesia. Under some circumstances, it might be difficult to perform, such as in edentulous patients, due to inadequate mask seal. We developed a new device called NIPARA and studied its use For ventilation optimization in edentulous patients.
  
  
  METHODS
  This randomized controlled trial included edentulous adults who had no other predictors of difficult airway, scheduled to undergo general anesthesia. Patients were assigned either to the NIPARA device group or to the control group (oral airway only). The primary outcomes were peak inspiratory pressure and tidal volume values of the first 14 breaths. The secondary outcome was the incidence of complications.
  
  
  RESULTS
  Data from 37 patients were collected during a one-year period (twenty in the NIPARA device group and 17 in the control group). The difference in mean PIP was not statistically significant. The tidal volume was 1.5 times greater in the NIPARA group than in the control group. One patient from the intervention group had minimal oral trauma.
  
  
  CONCLUSIONS
  In the administration of face mask ventilation, NIPARA is an effective device that significantly improves the tidal volume administered in edentulous patients.
authors.affiliation: a Department of Anesthesiology , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Niño
authors.affiliation: b Department of Oral Health , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: Andres
authors.initials: A
authors.lastname: Pauwels
authors.affiliation: a Department of Anesthesiology , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: Fernando
authors.initials: F
authors.lastname: Raffan
authors.affiliation: a Department of Anesthesiology , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: Enrique
authors.initials: E
authors.lastname: Arango
authors.affiliation: a Department of Anesthesiology , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Romero
authors.affiliation: a Department of Anesthesiology , Hospital Universitario Fundación Santa Fe de Bogotá , Bogotá , Colombia.
authors.forename: Daniel
authors.initials: D
authors.lastname: Benitez
mesh_terms: D000758:Anesthesia / Q000379:methods; D006801:Humans; D007575:Jaw, Edentulous; D008397:Masks; D010366:Peak Expiratory Flow Rate; D011175:Positive-Pressure Respiration / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D013990:Tidal Volume
keywords: Anesthesia; airway; edentulous; ventilation