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Does a protocol mandating a daily interruption of sedatives and spontaneous breathing trial improve patient outcome?
Lead Author: Dr Timothy Girard, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, USA. Timothy.girard@vanderbilt.edu. Three Part Clinical Question: Patients: Adult ICU patients expected to require mechanical ventilation for > 12hours. Intervention: Protocol of daily interruption of sedation (SAT) followed by SBT vs normal patient targeted sedation and SBT. Outcomes: Primary – ventilator free days in first 28 days, Secondary – time to ITU and hospital discharge, 28 day mortality, 1 year survival, duration of coma and delirium. Search Terms: Mechanical ventilation, Sedation, Weaning, Spontaneous breathing trials The Study: Non blinded, multi-centre randomised control trial with intention to treat. The study Patients: Adults admitted to one of four intensive care units in the USA between October 2003 and March 2006. Inclusion criteria: expected to require mechanical ventilation for > 12 hrs. Exclusion Criteria: post operative surgical patients, admission after cardiopulmonary arrest, already ventilated for > 2 weeks, death imminent, withdrawal of life support, profound neurology (large stroke/severe dementia) or already enrolled in another trial. 1658 considered eligible, 336 enrolled and randomised. SAT involved mandatory daily interruption of sedatives unless contraindicated (i.e >ICP, active myocardial ischemia, paralysed) and passed if opened eyes to verbal stimuli or tolerated sedative interruption for > 4hrs. SBT involved reducing support to either a T-tube or CPAP of 5cmH20 or PS < 7 and was failed if developed RR >35 or < 8, Sp02 < 88% for > 5mins, acute arrhythmia or two or more of HR> 130 or < 60, accessory muscle use, diaphoresis, abdominal paradox in 120 minutes. If passed SBT physician informed of result and extubated if they felt it appropriate. A ventilator free day was defined as a day breathing without assistance during the study period, starting with extubation (as long as the period of unassisted breathing lasted for at least 48 hours). Patients who died counted as 0 ventilator free days. Control Group: (n=168; 168 analysed): Patients received normal care with patient targeted sedation managed by clinical staff including sedation breaks as they felt appropriate and a daily SBT. Intervention Group: (n=168; 167 analysed): Patients received patient targeted sedation with a daily spontaneous awakening trial (interruption of sedation). If they passed this they went on to an SBT. If they failed the SAT - sedation was restarted at half previous dose and titrated as needed. The Evidence:
There was an increased incidence of self extubation in the intervention group but not an increased incidence of self extubation requiring re-intubation. EBM Comments: 1. Do the methods allow accurate testing of the hypothesis? Yes. 2. Do the statistical tests correctly test the results to allow differentiation of statistically significant results? Yes. 3. Are conclusions valid in light of the results? Yes. 4. Did results get omitted and why? Yes. One patient withdrew before starting protocol. 5. Did they suggest areas of further research? Yes. They recommended a repeat trial including postoperative surgical patients. These patients were excluded in this study because of concerns about interaction of analgesia requirements and sedation interruption. 6. Did they make any recommendations based on the results and were they appropriate? They appropriately recommend that a strategy of mandatory daily paired sedation break trials (unless contraindicated) and spontaneous breathing trials should become standard practice. 7. Is the study relevant to my clinical practice? Yes. 8. What level of evidence does this study represent? 1++ 9. What grade of recommendation can I make on this result alone? A. 10. What grade of recommendation can I make when this study is considered along with other available evidence? A . An increasing body of evidence in favour of daily sedative interruption. 11. Should I change my practice because of these results? Yes, if you do not already practice this intervention in your ICU. 12. Should I audit my current practice because of these results? Yes, although many ICUs claim to practice daily sedation breaks and breathing trials in practice this is not actually achieved as often as it should be. A mandatory daily protocol may help reduce this variability. Appraised by: Dr Michael Irvine, SpR Anaesthesia, Addenbrookes NHS Trust. Email: ingloss.lodge@btinternet.com © SICS EBMG 2009
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