Sedation Management AfteR Tracheostomy (SMART) study Koji Hosokawa, MD 1 Egi M., MD 2, Nishimura M., MD 3 1 Kyoto Prefectural Yosanoumi Hospital, Kyoto, Japan 2 Okayama, Japan, 3 Tokushima, Japan ANZICS CTG, Spring Research Forum 2012, Adelaide,, Australia
Tracheostomy in ICUs For 6 11% of patients staying in ICUs, tracheostomy is performed. Tracheostomy confirms safety airway, reduces sedation and assures patients comfort. Severinghaus JW (1998) AJRCCM Scales (2010) JAMA Nathens (2006) CCM
Midazolam use decreases after tracheostomy Trouillet JL (2011) Ann Int Med Nieszkowska A (2006) CCM
Retrospective observation in Japan Diagnosis Procedure Combination (like DRG PPS) data from 300 ICUs 7300 pts needed >2 day mechanical ventilation 1479 patients (20%) received tracheostomy Days from intubation to tracheostomy tracheostomy to discharge 12.8 days 67.1 days
100 90 80 70 60 50 40 30 20 10 0 In 1/3 of patients, sedation was stopped Patients used midazolam or propofol (%) after tracheostomy Tracheostomy 3 days 1 days +1 days +3 days +5 days
Early tracheostomy (2 7 days after intubation) may not reduce mortality No meta analysis because of heterogeneity Gomes Silva BN, 2012, Cochrane Database Syst Rev
Early tracheostomy (< 4 days after intubation) may not reduce mortality TracMan study, UK (RCT) Early (n=455) Late (n=454) Tracheostomy 93.1% 45.5% Mortality 139 (30.5%) 141 (31.1%) Duration of sedation 6.6 9.3 Complication 48 3 Young D, 2009, ISICEM
Tracheostomy Reduce sedation requirements Improve patients comfort, communication Rehabilitation Oral intake of nutrition, mouth hygiene Shorten mechanical ventilation days Reduce ventilator associated pneumonia Reduce mortality
Tracheostomy In whom tracheostomy reduces sedation? Improve patients comfort, communication Rehabilitation Oral intake of nutrition, mouth hygiene Shorten mechanical ventilation Reduce ventilator associated pneumonia Reduce mortality
Tracheostomy Who takes benefits of reducing sedatives Improve patients comfort, communication Rehabilitation Oral intake of nutrition, mouth hygiene Shorten mechanical ventilation Reduce ventilator associated pneumonia Reduce mortality
Sedation Management AfteR Tracheostomy (SMART) study Aim To clarify patients characters which predict less or no sedation after tracheostomy. To determine whether the reduction of sedatives after tracheostomy predict good prognoses or not.
Design of SMART Multicenter prospective observational study Inclusion criteria of SMART Adult (>20 years old) Those who receives tracheotomy during ICU stay
Data collection #1. The reasons for tracheostomy 1. CNS 2. Respiratory 3. Infection 3 2. Pneumonia, pulmonary infection 4. Circulation, CPA, shock 5. Neuromuscular disease 6. Upper airway obstruction (also general patient information, APHACHES II)
Data collection #2. Sedatives / analgesics On 3, 2, 1 day before tracheostomy On +1, 2, 3, 4, 5, 6, 7 day after tracheostomy Sedatives: hours of continuous infusion per 24 hrs. Analgesics: (Yes or No) Anti psychotics: (Yes or No) Muscle relaxants: (Yes or No)
Data collection #3. Patients prognosis and mortality On 30 and 60 day after tracheostomy Survival (Yes or No) and the day of death Ventilator dependency (Yes or No) and the day of relief from ventilator Hospital or ICU stay (Yes or No) and the day of discharge
Other data to collect Patient status at ICU admission (Age/Sex/APACHE II/General inf.) Reasons for ICU admission (Sur./Med./ER) Complication related to tracheostomy
Data analysis Primary outcome Patients characters which associate with sedative reduction after tracheostomy (ex. 3 day before vs. 5 day after) Secondary outcome Relation between sedative reduction and patients prognosis
Power analysis Probability of each patients character=0.3 Estimated Dif=20%, SD=40%, between on 3 day before and 5 day after tracheostomy α error=0.05, β error=0.2, estimated samples=200 patients.
The goal of the SMART study To specify in whom tracheostomy reduces sedation requirements To determine who takes benefits of reducing sedatives after tracheostomy. Sedation Management AfteR Tracheotomy study group Supported by Japanese Society of Intensive Care Medicine Leading investigator: Koji Hosokawa, MD
We are still discussing about Are there other useful data to collect? Which is the most important: a) hours of continuous drug infusion, b) total dose of drugs or c) depth of sedation? Is surveying within 28 days too short? Welcome your fruitful comments before starting the data collection (June, 2013).