2/27/2023 0 Comments Tt2 compendium![]() 70% cooled with external devices and 30% with intravascular devices.Rewarming began after 28 hours (increase temperature by no more than 0.3☌ per hour until 40 hours).A feedback-controlled system used to maintain target temperature (bladder temperature probe).Rapid cooling achieved by cold fluids and physical cooling devices (surface or intravascular devices).Hypothermia group: target temperature 33C.Defined as SBP 30 minutes or evidence of end-organ hypoperfusion.Baseline characteristics between groups (Hypothermia vs Normothermia).1850 analysed for survival (11 lost to follow-up).930 in Hypothermia arm, 931 in Normothermia arm.1861 analysed as intention to treat (39 withdrew consent).Unconscious: as defined by the FOUR score motor response 180 minutes since ROSC, non-cardiac cause for arrest, not unconscious, limitations to care in place.Sustained ROSC: >20 minutes of circulation without need for chest compressions.Out-of-hospital cardiac arrest of presumed cardiac or unknown cause.Last data collection: 6-month follow-up completed mid 2020 with 24 month follow-up ongoing.Active recruiting through 2018 to early 2020 Dates of randomisation: pilot phase began late 2017.Highest recruiting countries: Sweden, UK, Switzerland, France, Czech Republic.Number of countries: 14 countries, 61 institutions.This was increased to 1900 to account for loss to follow-up Power Calculation: A total of 1862 participants gave a power of 90% (alpha 0.05, NNT 13.3) to detect an absolute risk reduction of 7.5% in mortality (assuming 55% mortality).MRS was performed via a structured interview with interviewers receiving formal training.Where possible the patient and a proxy were used to obtain information Outcome assessment was by face-to-face interview (72%) or telephone interview (particularly used when the COVID-19 pandemic began).Duplicate manuscripts were written for each scenario before randomisation was revealed.Non blinded clinicians, however assessors of prognosis, participants, outcome assessors, statisticians, data managers blinded.Outcomes assessed at 30 days, 6 months, 24 months (ongoing).Pre-specified secondary outcomes (neurological outcome and health related quality of life) and subgroup analyses (sex, age, time to ROSC, initial rhythm and whether shock present on admission).Web-based allocation using permuted blocks of varying sizes (stratified by site + TAME randomisation) in 1:1 ratio.Randomisation occurred in the emergency department.Co-enrolment with the TAME trial (Targeted Therapeutic Mild Hypercapnia).International, multicentre, parallel group trial.Fever is associated with worse outcomes.avoidance of fever (> 37.7☌) for at least 72 h after ROSC in patients who remain in coma.maintaining a target temperature at a constant value between 32 and 36☌ for at least 24 h.The European Resuscitation Council released new guidelines in March 2021.The HYPERION trial (n=584) showed that in patients with coma following a non-shockable cardiac arrest, the use of moderate hypothermia improved favourable neurological outcome at 90 days compared with targeted normothermia.They reported no significant difference in all-cause mortality 36☌ in patients with an out-of-hospital cardiac arrest from a presumed cardiac cause. The TTM (2013) study (n=950) compared a targeted temperature of 33☌ vs.A number of patients in the control group developed fever and it was therefore unclear if the reported benefits were from hypothermia or the avoidance of fever ![]() However, small sample sizes and other methodological flaws meant the evidence was of low certainty. The HACA trial (n=137) and Bernard trials (n=77) published in NEJM in 2002 reported that therapeutic hypothermia following a VF arrest improved favourable neurological outcome.There have been several randomised trials investigating temperature management following cardiac arrest.In patients who are unconscious following out-of-hospital cardiac arrest, does targeted hypothermia compared with targeted normothermia, impact all-cause mortality?.Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrestĭankiewicz J for the TTM2 Trial Investigators. ![]()
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