title: Evaluation of a systematic approach to weaning of tracheotomized neurological patients: an early interrupted randomized controlled trial.
abstract: BACKGROUND
  While a systematic approach to weaning reduces the rate of extubation failure in intubated brain-injured patients, no data are available on the weaning outcome of these patients after tracheotomy. We aimed to assess whether a systematic approach to disconnect tracheotomized neurological and neurosurgical patients off the ventilator (intervention) is superior to the sole physician's judgment (control). Based on previous work in intubated patients, we hypothesized a reduction of the rate of failure within 48 h from 15 to 5 %. Secondary endpoints were duration of mechanical ventilation, ICU length of stay and mortality.
  
  
  METHODS
  We designed a single center randomized controlled study. Since no data are available on tracheotomized patients, we based our a priori power analysis on results derived from intubated patients and calculated an overall sample size of 280 patients.
  
  
  RESULTS
  After inclusion of 168 consecutive patients, the trial was interrupted because the attending physicians judged the observed rate of reconnection to be much greater than expected. The overall rate of failure was 29 %, confirming the physicians' judgment. Twenty-one patients (24 %) in the intervention group and 27 (33 %) controls were reconnected to the ventilator within 48 h (p = 0.222). The main reasons for failure were respiratory distress (80 and 88 % in the treatment and control group, respectively), hemodynamic impairment (15 and 4 % in the treatment and control group, respectively), neurological deterioration (4 % in the control group only). The duration of mechanical ventilation was of 412 ± 202 h and 402 ± 189 h, in the control and intervention group, respectively. ICU length of stay was on average of 23 days for both groups. ICU mortality was 6 % in the control and 2 % in the intervention group without significant differences.
  
  
  CONCLUSIONS
  We found no difference between the two groups under evaluation, with a rate of failure much higher than expected. Consequent to the early interruption, our study results to be underpowered. Based on the results of the present study, a further trial should overall enroll 790 patients.
  
  
  BACKGROUND
  ACTRN12612000372886.
authors.affiliation: Anesthesia and Intensive Care Medicine, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. rosanna.vaschetto@med.uniupo.it.
authors.forename: Rosanna
authors.initials: R
authors.lastname: Vaschetto
authors.affiliation: Dipartimento di Neuroscienze, Azienda Ospedaliera Niguarda Ca' Granda, Piazza Dell'Ospedale Maggiore 3, 20162, Milano, Italy. pamelafrigerio@gmail.com.
authors.forename: Pamela
authors.initials: P
authors.lastname: Frigerio
authors.affiliation: Dipartimento di Neuroscienze, Azienda Ospedaliera Niguarda Ca' Granda, Piazza Dell'Ospedale Maggiore 3, 20162, Milano, Italy. maursom@gmail.com.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Sommariva
authors.affiliation: Anesthesia and Intensive Care Medicine, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. arianna.boggero@fastwebnet.it.
authors.forename: Arianna
authors.initials: A
authors.lastname: Boggero
authors.affiliation: Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale "Amedeo Avogadro", Alessandria-Novara-Vercelli, via Solaroli 17, 28100, Novara, Italy. valerondi88@gmail.com.
authors.forename: Valentina
authors.initials: V
authors.lastname: Rondi
authors.affiliation: Anesthesia and Intensive Care Medicine, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. francesca.grossi.md@gmail.com.
authors.forename: Francesca
authors.initials: F
authors.lastname: Grossi
authors.affiliation: Department of Infrastructure Research and Statistics, IRCCS-Arcispedale Santa Maria Nuova, Viale Umberto I 50, 42123, Reggio Emilia, Italy. Silvio.Cavuto@asmn.re.it.
authors.forename: Silvio
authors.initials: S
authors.lastname: Cavuto
authors.affiliation: Respiratory and Critical Care, Department of Specialistic, Diagnostic and Experimental Medicine (DIMES), Alma Mater Studiorum, Sant'Orsola Malpighi Hospital, University of Bologna, Via Zamboni 33, 40126, Bologna, Italy. stefanava@gmail.com.
authors.forename: Stefano
authors.initials: S
authors.lastname: Nava
authors.affiliation: Anesthesia and Intensive Care Medicine, Maggiore della Carità Hospital, Corso Mazzini 18, 28100, Novara, Italy. dellacorte.f@gmail.com.|Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale "Amedeo Avogadro", Alessandria-Novara-Vercelli, via Solaroli 17, 28100, Novara, Italy. dellacorte.f@gmail.com.
authors.forename: Francesco Della
authors.initials: FD
authors.lastname: Corte
authors.affiliation: Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale "Amedeo Avogadro", Alessandria-Novara-Vercelli, via Solaroli 17, 28100, Novara, Italy. paolo.navalesi@med.unipmn.it.|Anesthesia and Intensive Care Medicine, Sant'Andrea Hospital, C.so M. Abbiate 21, 13100, Vercelli, Italy. paolo.navalesi@med.unipmn.it.|CRRF Mons. L. Novarese, Moncrivello, Localita' Trompone, 13040, Vercelli, Italy. paolo.navalesi@med.unipmn.it.
authors.forename: Paolo
authors.initials: P
authors.lastname: Navalesi
keywords: Brain-injured patients; Tracheotomy; Weaning