Recent Articles In Trauma

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Presentation transcript:

Recent Articles In Trauma Dr.JSK Chaitanya DNB (Gen Medicine), IDCCM, EDIC Consultant Intensivist Royal Care Superspeciality Hospital,Coimbatore

PAMPER TRIAL POLAR-RCT Permissive hypotension in critically ill haemorrhagic shock patients Betablockers in severe TBI ATLS UPDATES ZERO POINT SURVEY

PAMPER TRIAL NEJM July 2018

What is already known An initial, warmed fluid bolus of isotonic fluid. The usual dose is 1 liter for adults for patients in hemorrhagic shock – ATLS 10TH EDITION

PAMPER TRIAL Why ? To determine the efficacy and safety of prehospital administration of thawed plasma in injured patients who are at risk for hemorrhagic shock. How? Pragmatic , multicenter, cluster-randomized, phase 3 superiority trial that compared the administration of thawed plasma with standard-care resuscitation during air medical transport. What? Primary outcome was mortality at 30 days.

PAMPER TRIAL Team in ambulances screened and enrolled patients Randomisation was of air medical services (2 to 6 bases or helicopters per service), and not individual patients. These were block randomized and assigned to the plasma arm or standard care (control) arm for 1 month at a time. No blinding of prehospital and hospital staff, but trial assessors were blinded Assuming a 1:1 randomization of 32 clusters or 16 patients each, 530 patients (504 eligible patients with complete data) would provide the trial with 88% power to detect a difference of 14 percent age points (8.0% vs. 22.0%) in 30-day mortality Statistical significance for the primary analysis (P<0.038) was adjusted for two interim analyses by the external data safety monitoring board

PAMPER TRIAL Inclusion: Blunt or penetrating trauma patients, and Transported from a scene of their injury or from an outside referral ED to a participating trauma centre, and At risk of haemorrhagic shock, as defined by at least one episode of: Hypotension (systolic blood pressure <90mmHg) and tachycardia (HR>108/min) Severe hypotension (systolic blood pressure <70mmHg)

Exclusion: >90 years old or <18 years old Unable to establish IV or IO access Isolated fall from standing Documented cervical cord injury Known to be a prisoner Pregnant Traumatic cardiac arrest >5 minutes Penetrating brain injury Isolated drowning or hanging >20% TBSA burns Admitted to an outside referral hospital Patient or family member objected to participation in the trial at the scene

PAMPER TRIAL A total of 501 patients were enrolled 390 enrolled directly at scene, while 111 transferred from a non-trauma centre emergency department 72.7% were men Median age 45 years old 82.4% had blunt trauma High risk trauma population Median injury severity score 22 (13-30) Median MAP 70 Median HR 116 Prehospital intubation in 51.1% 34.7% received prehospital red blood cells 58.4% had urgent operations in initial 24hours Overall mortality 29.6% Similar baseline demographics, prehospital vital signs, and injury scores in all areas except Prehospital crystalloid was lower in plasma group median 500mls (0-1250) vs 900mls (0-1500) Prehospital RBC transfusion was lower in plasma group 26.1% vs 42.1%

PAMPER TRIAL Intervention Air medical bases randomized to the intervention were provided with 2 units of thawed plasma stored in coolers with a temperature between 1 to 10 degrees (either group AB (“universal donor”) or group A with a low anti-B antibody ) Plasma was initiated in prehospital setting by air transport team before other resuscitative fluids were given The infusion was required to be completed once started Following completion of the plasma, goal directed resuscitation as described below continued until arrival at trauma centre, including the infusion of crystalloids and or RBCs Control Goal-directed, crystalloid-based resuscitation targeting a systolic blood pressure of ≥90mmHg This was not standardised, but was guided by local  air ambulance protocols Management common to both groups In addition to above crystalloid resuscitation, 13/27 air transport teams also carried 2 units of universal donor red cells RBC transfusion was indicated if after 1L of crystalloid there was ongoing Hypotension with systolic blood pressure <90mmHg Changes in mental status Tachycardia with heart rate >120 beats per minute Capillary refill >2 seconds

Primary outcome 30 day Mortality -(23.2% vs. 33.0%; difference, −9.8% ;p = 0.03 The Kaplan– Meier survival curves showed an early separation of the two groups that began 3 hours after randomization and remained until 30 days (720 hours) after randomization P = 0.02

Secondary outcomes

Does it change the way I manage? In patients at risk for hemorrhagic shock, the administration of thawed plasma during prehospital air medical transport was safe and resulted in lower 30-day mortality and a lower median prothrombin-time ratio than standard-care resuscitation.

POLAR TRIAL JAMA, October 2018

What is already known Lewis SR, Evans DJW, Butler AR, Schofield-Robinson OJ, Alderson P.Hypothermia for traumatic brain injury.Cochrane Database of Systematic Reviews2017, Issue 9. Art. No.: CD001048.

POLAR TRIAL Why? To determine the effectiveness of early prophylactic hypothermia compared with normothermic management of patients after severe traumatic brain injury. How? Multicenter randomized trial in 6 countries that recruited 511 patients both out-of-hospital and in emergency departments after severe traumatic brain injury. What? Favorable neurologic outcomes or independent living (Glasgow Outcome Scale–Extended score, 5-8) obtained by blinded assessors 6 months after injury.

POLAR TRIAL INCLUSION CRITERIA EXCLUSION CRITERIA Eligible patients with head injuries were estimated to be aged 18 to 60 years had a GCS of less than 9 actual or imminent endotracheal intubation EXCLUSION CRITERIA Significant bleeding suggested by systolic hypotension (<90 mm Hg) OR Sustained tachycardia (>120/min) Suspected pregnancy Possible uncontrolled bleeding, GCS – 3 and unreactive pupils Destination hospital not a study site

POLAR TRIAL BASELINE CHARACTERSTICS Predominantly men Mean age of 34.5 years (SD, 13.4) Median Glasgow Coma Scale score of 6 The majority of patients (70.6%) had diffuse brain injury (brain swelling or hemorrhages, without subdural or extradural brain hematomas), The median time from injury to randomization was 1.9 hours

POLAR TRIAL INTERVENTION HYPOTHERMIA INDUCTION MAINTENANCE patient exposure, a bolus of up to 2000 mL intravenous ice-cold (4°C) 0.9% saline surface-cooling wraps targeting an initial core temperature of 35°C and 33 °C after excluding significant risks for bleeding. MAINTENANCE Maintained at 33°C (or 35°C if bleeding concerns persisted) with a Gaymar Meditherm 3 console with surface-cooling wraps for at least 72 hours after randomization. Can be rewarmed to 35 °C if hemodynamic instability or bleeding occurs.

POLAR TRIAL REWARMING NORMOTHERMIA If the ICP <20 mm Hg, gradual controlled rewarming was commenced at a target rate up to 0.25°C/h. If the ICP> 20, recooled , assessed again for reduction in ICP Maximum duration of 7 days. patients were maintained normothermic with automated surface-cooling wraps for up to 7 days postrandomization NORMOTHERMIA Temperature target was 37°C ― 0.5°C. Surface-cooling wraps could be used to manage pyrexia or refractory intracranial hypertension General managent based on international TBI guidelines

POLAR TRIAL No significant differences in primary outcomes or in secondary outcomes

Does it change the way I manage? Among patients with severe traumatic brain injury, early prophylactic hypothermia compared with normothermia did not improve neurologic outcomes at 6 months. These findings do not support the use of early prophylactic hypothermia for patients with severe traumatic brain injury.

Permissive Hypotension vs Permissive Hypotension vs. Conventional Resuscitation Strategies in Adult Trauma Patients with Hemorrhagic Shock: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

What is already known In patients with hemorrhagic shock, permissive hypotensive resuscitation is adviced prior to achieving hemostasis when ICP is not raised.- ATLS 10TH edition Level of Evidence –III

only randomized studies Studies evaluating adult patients with penetrating or blunt traumatic injury and suspicion of hemorrhage Both civilian and military Isolated head injuries excluded. only randomized studies

4 of the studies showed reduced mortality but for only one study with significance.

3 trials recorded lesser blood product tx 2 trials recorded higher crystalloid requirement in control arm 2 trials recorded lesser blood loss estimates

Does it change the way I manage Based on the pooled findings of five randomized controlled trials, a survival benefit for lower blood pressure targets as compared to conventional resuscitation thresholds is noted. Patients receiving permissive hypotension have lower reported blood loss volumes reduced blood product utilization lower volumes of crystalloid administration Ideal blood pressure target for such a strategy remains unclear. Level of evidence – level II

ATLS 2018-19 TENTH EDITION

What is already known TBI management guidelines emphasize on prevention of secondary injuries like hypoxia or hypothension. Evidence in prevention of progression of secondary injuries so far have not yielded much of results

What? Hypothesis that beta blocker use after TBI is associated with lower mortality, and secondarily compared propranolol to other beta blockers. How ? Multi - institutional,prospective, observational trial in which adult TBI patients who required ICU admission were compared based on beta blocker administration

Inclusion criteria Age > 18 years Blunt traumatic injury CT of the brain demonstrating an acute TBI ICU admission at presentation. Sample size calculation was based on an overall mortality of 10% for a similar group of TBI patients who survived until ICU admission

Fishers test Student's t test or Mann-Whitney U-test Multivariate logistic regression analysis p < 0.05 was considered statistically significant The primary outcome was 30-day mortality. Secondary outcomes – GOS (4-5 VS 1-3 ) , HOSPITAL LENGTH OF STAY

Limitations of the study Management of TBI was not uniform among study sites. The optimal type and dose required has yet to be delineated. Differences in the baseline characteristics of the cohorts - addressed by multivariate regression Selection bias Lack of data on other interventions.

Does it change the way I manage? Administration of beta blockers after TBI was associated with improved survival, before and after adjusting for the more severe injuries observed in the treatment cohort Level of Evidence : Level III

Zero point survey Clin Exp Emerg Med 2018;5(3):139-143

Current understanding Standard resuscitation teaching begins with the primary survey. No technical skills- rarely taught Environmental aspects- often left out.

COGNITIVE ROADMAP FOR RESUSCITATION PRIMARY SURVEY IDENTIFY PRIORITISE threats to life TEMPORIZE TEAM ENVIRONMENT EQUIPMENT COGNITIVE ROADMAP FOR RESUSCITATION

Why is it important? More complex frail patients Large teams Changing personnel Diagnostic ambiguities Cognitive bias FACILITATE PROBLEM IDENTIFICATION ERROR AVOIDANCE SITUATION AWARENESS BETTER PLACEMENT OF EQUIPMENT SAFE ENVIRONMENT ZERO POINT SURVEY BETTER TEAM RESILIENCE SUCCESFUL OUTCOME

When and where? When? Where? Start of the shift Prior to arrival of the patient During resuscitation in dynamic scenarios Where? Emergencies ICU’s OT’s Rapid response teams Code Blue teams

Self check physical Personal readiness Cognitive TEAM LEADER Illness Medication/drugs Stress Alcohol Fatigue Eating/elimination Cognitive BREATHE TALK SEE FOCUS Team readiness TEAM LEADER ASSIGNMENT OF ROLES

TEAM BRIEF TASK WORK What needs to be done? TEAM WORK How the team works ? UPDATES PRIORITIES

“Is there enough space to safely manage this patient? ENVIRONMENTAL SCAN DANGERS COMBATIVE PATIENT EXPOSED BODY FLUIDS TRIP/FALL HAZARDS SPACE “Is there enough space to safely manage this patient? LIGHT NOISE CROWD

PS could also benefit from a prequel Take home Non-technical skills and human factors are increasingly recognized as critical ingredients in the success or failure of acute care delivery . Increase the likelihood of patient rescue and to help create and maintain robust resuscitation teams. PS could also benefit from a prequel ZERO POINT SURVEY

TEAM WORK WORKS THANK YOU