Research

A prospective trial of elective extubation in brain injured patients meeting extubation criteria for ventilatory support: a feasibility study

Edward M Manno¹ , Alejandro A Rabinstein¹ , Eelco FM Wijdicks¹ , Allen W Brown² , William D Freeman⁵ , Vivien H Lee¹ , Stephen D Weigand³ , Mark T Keegan⁴ , Daniel R Brown⁴ , Francis X Whalen⁴ , Tuhin K Roy⁴ and Rolf D Hubmayr⁵

¹Department of Neurology, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA

²Department of Physical Medicine and Rehabilitation, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA

³Department of Biostatistics, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA

⁴Department of Anesthesiology, Mayo Clinic College of Medicine, 200 First Street SW, Rochester, MN 55905, USA

⁵Department of Neurology, Mayo Clinic College of Medicine, 4500 San Pablo Road, Jacksonville, FL 32224, USA

author email corresponding author email

Critical Care 2008, 12:R138doi:10.1186/cc7112

Published:	10 November 2008

Abstract

Introduction

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.