title: A prospective trial of elective extubation in brain injured patients meeting extubation criteria for ventilatory support: a feasibility study.
abstract: BACKGROUND
  To assess the safety and feasibility of recruiting mechanically ventilated patients with brain injury who are solely intubated for airway protection and randomising them into early or delayed extubation, and to obtain estimates to refine sample-size calculations for a larger study. The design is a single-blinded block randomised controlled trial. A single large academic medical centre is the setting.
  
  
  METHODS
  Sixteen neurologically stable but severely brain injured patients with a Glasgow Coma Score (GCS) of 8 or less were randomised to early or delayed extubation until their neurological examination improved. Eligible patients met standard respiratory criteria for extubation and passed a modified Airway Care Score (ACS) to ensure adequate control of respiratory secretions. The primary outcome measured between groups was the functional status of the patient at hospital discharge as measured by a Modified Rankin Score (MRS) and Functional Independence Measure (FIM). Secondary measurements included the number of nosocomial pneumonias and re-intubations, and intensive care unit (ICU) and hospital length of stay. Standard statistical assessments were employed for analysis.
  
  
  RESULTS
  Five female and eleven male patients ranging in age from 30 to 93 years were enrolled. Aetiologies responsible for the neurological injury included six head traumas, three brain tumours, two intracerebral haemorrhages, two subarachnoid haemorrhages and three ischaemic strokes. There were no demographic differences between the groups. There were no unexpected deaths and no significant differences in secondary measures. The difference in means between the MRS and FIM were small (0.25 and 5.62, respectively). These results suggest that between 64 and 110 patients are needed in each treatment arm to detect a treatment effect with 80% power.
  
  
  CONCLUSIONS
  Recruitment and randomisation of severely brain injured patients appears to be safe and feasible. A large multicentre trial will be needed to determine if stable, severely brain injured patients who meet respiratory and airway control criteria for extubation need to remain intubated.
authors.affiliation: Department of Neurology, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA. manno.edward@mayo.edu
authors.forename: Edward M
authors.initials: EM
authors.lastname: Manno
authors.forename: Alejandro A
authors.initials: AA
authors.lastname: Rabinstein
authors.forename: Eelco F M
authors.initials: EF
authors.lastname: Wijdicks
authors.forename: Allen W
authors.initials: AW
authors.lastname: Brown
authors.forename: William D
authors.initials: WD
authors.lastname: Freeman
authors.forename: Vivien H
authors.initials: VH
authors.lastname: Lee
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Weigand
authors.forename: Mark T
authors.initials: MT
authors.lastname: Keegan
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Brown
authors.forename: Francis X
authors.initials: FX
authors.lastname: Whalen
authors.forename: Tuhin K
authors.initials: TK
authors.lastname: Roy
authors.forename: Rolf D
authors.initials: RD
authors.lastname: Hubmayr
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001930:Brain Injuries / Q000209:etiology / Q000503:physiopathology; D003657:Decision Making; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007442:Intubation, Intratracheal; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D015599:Trauma Severity Indices