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Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 Contents: 1) Indications 2 2) Exclusion criteria 3 3) Essential patient resources 3 4) Optional patient resources 3 5) Nursing staffing 4 6) Patient monitoring 4 7) Endotracheal intubation and mechanical ventilation 5 8) Shiver suppression and management 5 9) Hypothermia induction and maintenance 8 10) Rewarming 9 11) Patient management issues (DVT prophylaxis, nutrition, potassium) 9 12) Modified Bedside Shiver Assessment Scale (mBSAS) and interventions reference 03.04.2010 1 of 10 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 1) Consider using hypothermia in the following: a) Post Cardio-Pulmonary Resuscitation i) Inclusion Criteria: (1) Age 18 years old (2) Cardio-Pulmonary arrest with return of spontaneous circulation (ROSC) (3) Persistent coma as evidenced by no eye opening to pain after resuscitation (no minimum waiting period required) (4) Systolic Blood Pressure can be maintained > 90 mm Hg or Mean Arterial Pressure (MAP) > 60 mmHg either spontaneously or with fluids and low/moderate dose pressors (5) Known time of cardiac arrest (excludes prolonged “found down”) (6) No limit on duration of resuscitation effort; however less than 1 hour most desirable (7) Able to initiate therapy within 6 hours of ROSC – ideally within 1 hour b) Acute ischemic stroke and Spontaneous Intracranial Hemorrhage i) Inclusion criteria: (1) Age 18 years old (2) Moderate to severe stroke (NIH Stroke Scale score 8) (a) And/or radiographic findings predictive for significant neurologic impairment (i.e. large MCA stroke, lobar ICH > 30 mL, etc.) (b) And/or radiographic indications of increased ICP (significant cerebral edema, shift, etc.) (3) Systolic Blood Pressure can be maintained > 90 mm Hg or Mean Arterial Pressure (MAP) > 60 mmHg either spontaneously or with fluids and low/moderate dose pressors (not aortic balloon pump) (4) Able to initiate therapy within 12-24 hours of symptom onset – ideally within 2-3 hours of symptom onset c) Traumatic Brain Injury i) Inclusion criteria: (1) Age 18 years old (2) Glasgow Coma Scale < 8 (3) Radiographic indications of increased ICP (significant cerebral edema, shift, etc.) (4) Systolic Blood Pressure can be maintained > 90 mm Hg or Mean Arterial Pressure (MAP) > 60 mmHg either spontaneously or with fluids and low/moderate dose pressors (not aortic balloon pump) (5) Able to initiate therapy within four hours of trauma 03.04.2010 2 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 d) Refractory Increased Intracranial Pressure i) Inclusion criteria: (1) Age 18 years old (2) Intracranial pressure > 25 mmHg despite maximal medical therapy (if intracranial pressure monitoring used). If ICP monitoring is not used, follow recommendations in (3) below (3) Clinical and/or radiographic indication(s) of significantly increased ICP despite maximal medical therapy (4) Systolic Blood Pressure can be maintained > 90 mm Hg or Mean Arterial Pressure (MAP) > 60 mmHg either spontaneously or with fluids and low/moderate dose pressors (not aortic balloon pump) e) Refractory seizures (status epilepticus) i) Inclusion criteria: (1) Age 18 years old (2) Continuous seizure activity or recurrent seizures without a return to preictal functioning (a) In the setting of at least 2 medications [i.e. Lorazepam (Ativan) and Phenytoin (Dilantin)] (3) Systolic Blood Pressure can be maintained > 90 mm Hg or Mean Arterial Pressure (MAP) > 60 mmHg either spontaneously or with fluids and low/moderate dose pressors (not aortic balloon pump) 2) Exclusion Criteria i) Sepsis ii) Persistent, hemodynamically significant cardiac dysrhythmias iii) Pregnancy (relative contraindication) iv) Known, pre-existing clinically significant coagulopathy or bleeding v) Pre-existing illness limiting life-expectancy to < 6 months vi) Pre-existing significant neurological disability (modified Rankin Scale Score > 2) vii) Patient has a known hypersensitivity to hypothermia (Raynaud’s disease, sickle cell disease, cryoglobulinemia, etc.) 3) Essential patient resources include: a) Standard ICU monitoring b) Salem sump oro-gastric tube c) Foley catheter d) Medi-therm III Hypothermia machine with 2 sets of hoses and one set of RaprRound wraps (Torso and Legs x 2) e) Esophageal temperature probe f) BIS monitor 4) Optional patient resources include: a) CVP or PA catheter (preferably positioned in the Subclavian Vein) is optional but recommended (if needed, may initiate therapy before central line placed) b) Arterial pressure line (if needed, may initiate therapy before arterial line placed) 03.04.2010 3 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 5) Nursing staffing: Therapeutic mild hypothermia does not require a 1:1 assignment, however, during therapy induction (1-2 hours) the patient will require a 1:1 nurse with no other assignment during this period. Nurses caring for patients undergoing therapeutic hypothermia must not have an assignment of more than 1:2 6) Patient monitoring a) Continuous and record hourly i) Cardiac monitor ii) Oxygen saturation iii) BIS monitor iv) Shiver assessment b) Every 15 minutes, record until the patient has reached target 330 C (91.40 F), then hourly i) Core Temperature ii) Blood pressure c) Every 1 hours i) Initiate IV insulin protocol d) Baseline diagnostics and labs (therapy may start before the lab results are available) i) 12 lead ECG ii) Portable CXR iii) Arterial blood gases iv) CBC with diff v) PT/INR/aPTT vi) CMP, Magnesium and Phosphorus vii) Lactate viii) Cardiac profile ix) Urinalysis (culture if indicated) a) Every 6 hours i) BMP ii) Magnesium iii) Cardiac profile b) Every 24 hours i) Portable chest X-Ray (if indicated) ii) Arterial blood gases iii) CBC with diff iv) PT/INR/aPTT v) CMP, Magnesium and Phosphorus vi) Lactate 03.04.2010 4 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 2) Endotracheal intubation and mechanical ventilation a) Endotracheal intubation and mechanical ventilation is usually needed to induce therapeutic hypothermia with surface cooling techniques. However, this therapy may be attempted without mechanical ventilation in selected cases. If the patient is intubated: i) Assure and maintain appropriate endotracheal tube placement per standard protocol ii) Ventilator setting as appropriate for the patient’s presenting condition(s) 3) Shiver suppression and management a) Induction of shivering suppression protocol i) Shiver is a MAJOR clinical issue with therapeutic hypothermia. Each patient should be observed closely for shiver. In addition to visual monitoring, the nurse should gently palpate the patient’s masseters (jaw), pectoralis, and deltoids every 30 to 60 minutes. In addition, fine fluctuations on the patient’s cardiac rhythm tracing as well as an unexplained/sudden increase in BIS values or fine fluctuations in the BIS tracing may also indicate shiver. ii) Shiver suppression should be based on the modified Bedside Shivering Assessment Scale (mBSAS). Assess and record the patient’s mBSAS every 30 – 60 minutes and prn. Palpate the following muscle groups – masseters (jaw), pectoralis, deltoids, and quadriceps. 0 – No shiver 1 – MILD = shivering localized to the neck and/or thorax; or fine artifact on cardiac rhythm; or fine artifact on BIS tracing; or unexplained, significant increase in BIS value 2 – MODERATE = shivering involves gross movement of the upper extremities (in addition to neck and thorax) 3 – SEVERE = shivering involves gross movements of the trunk and upper and lower extremities (1) Interventions for shiver suppression should be step-wise and based on the mBSAS 0 – No Shiver Optimize sedation and analgesia Dexmedetomidine (Precedex) or Propofol (Diprivan) infusion Fentanyl drip Alter shiver threshold Buspirone (BusPar) by gastric tube Vasodilatation Magnesium drip 1 – MILD Continue 03.04.2010 5 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 Optimize sedation and analgesia Dexmedetomidine (Precedex) or Propofol (Diprivan) infusion Fentanyl infusion Alter shiver threshold Buspirone (BusPar) by gastric tube Vasodilatation Magnesium drip Add Meperidine (Demerol) 12.5 mg IV bolus dose 2 – MODERATE Continue same interventions as with score of 1 above and increase Meperidine (Demerol) to 25 mg IV bolus dose 3 – SEVERE Optimize sedation and analgesia Dexmedetomidine (Precedex) or Propofol (Diprivan) infusion Fentanyl drip Alter shiver threshold Buspirone (BusPar) by gastric tube Meperidine (Demerol) IV bolus Vasodilatation Magnesium drip Add Neuromuscular blockade Vecuronium (Norcuron) intermittent boluses iii) Specific instructions for shiver suppression/management (1) Initiation of therapy (a) Lorazepam (Ativan) only use lorazepam bolus if the patient is not already adequately sedated at the initiation of therapy (i) Bolus 4 mg IV push x 1 over 2 minutes (2) Maintenance of therapy (should be maintained till the patient has been returned to a core temperature of 360 C (a) Continuous sedation (i) Patients undergoing therapeutic hypothermia must be adequately sedated. The clinician should select either Dexmedetomidine (Precedex) or Propofol (Diprivan) based on the clinical situation (ii) Dexmedetomidine (Precedex) is associated with a lower incidence of induced delirium, however, the bradycardic side-effects of this agent may limit it’s suitability in selected patients. Consider using Propofol (Diprivan) in patients with persistent bradycardia below 35 bpm (iii) Dexmedetomidine (Precedex) (to provide shiver suppression and continuous sedation) 1. Bolus 1 mcg/kg over 10 minutes, then 2. Continuous infusion at 0.2 – 1.5 mcg/kg/hour 03.04.2010 6 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 (b) (c) (d) (e) (f) 03.04.2010 3. Maintain BIS reading of 40 - 60 (iv) Propofol (Diprivan) (to provide shiver suppression and continuous sedation) 1. Continuous infusion at 20 mcg/kg/min 2. Titrate by 5-10 mcg/kg/min every 10 minutes 3. Maintain BIS reading of 40 – 60 Vecuronium (Norcuron) (only AFTER adequate sedation achieved) (i) Bolus 0.1 mg/kg x 1 at therapy initiation, and (ii) Re-bolus Vecuronium 0.1 mg/kg prn shivering (mBSAS = 3) (iii) Do not use continuous infusion Fentanyl (adjunctive therapy for shiver suppression and sedation) (i) Bolus 50 mcg IV push and repeat every 30 minutes until the continuous infusion is initiated (ii) Continuous infusion at 2 – 5 mcg/kg/hour Buspirone (BusPar) [(pharmacologically lowers the shiver threshold, and this effect is synergistic with Dexmedetomidine (Precedex) and propofol (Diprivan)] (i) Initial dose 30 mg by gastric tube then, (ii) 15 mg by gastric tube every 8 hours until rewarmed to 360 C Magnesium drip (vasodilatation – improves efficacy of cooling and increases patient comfort) (i) Prepare 12 grams Magnesium Sulfate in 250 mL of normal saline (ii) Continuous infusion at 10 mL/hr (iii) Titrate to maintain a serum magnesium level of 3 – 4 mg/dL (iv) Monitor serum magnesium levels every 6 hours Meperidine (Demerol) (pharmacologically lowers the shiver threshold and is synergistic with buspirone) (i) 25 mg IV bolus x 1 prn initially, then (ii) 12.5 mg IV bolus every 30 minutes PRN mild shiver (mBSAS 1) (iii) 25 mg IV bolus every 30 minutes PRN moderate shiver (mBSAS 2) 7 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 4) Hypothermia induction, maintenance and rewarming – see below Hypothermia induction and maintenance Place esophageal continuous temperature probe Turn on the machine and fill the wraps with water before placing on the patient Torso wrap and leg wraps o Apply Torso wrap directly on the patient Therapy induction o If initial core temperature > 34.50 C – use cold saline infusion Infuse cold NS (kept in medication refrigerator) 1000 mL x 2 over 10 minutes each (use a pressure bag) o After initial boluses, give an additional volume of cold saline to make a final volume of 40 mL/kg o If core temperature reaches 340 C, discontinue cold NS infusion o Connect the temperature probe to the Medi-therm III Cooling Machine and set on AUTO – RAPID Mode and the Set-Point = 330 C o If initial core temperature < 34.50 C – do not use cold saline infusion. Proceed with initiation as above and follow therapy maintenance protocol below Therapy maintenance o If the core temperature is at anytime below 310 C Immediately initiate active warming until the core temperature returns to 330 C Remove cloth blankets and gown Open torso wrap and leg wraps (but do not remove) Place warm air blanket on patient and set at 400 C Once the core temperature is > 320 C Remove warm air blanket Reapply torso and leg wraps Restart cooling with the Cooling Machine AUTO setting at 330 C 03.04.2010 8 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 5) Rewarming – the goal is to actively, but in a controlled and gradual fashion, rewarm the patient to a normal temperature over 24 hours, and maintain a normal temperature for at least 24 additional hours a) Set the machine on AUTO / GRADUAL with set-point 370 C. This setting will rewarm at a rate of 0.170 C per hour b) Once the patient’s core temperature reaches 360 C i) Discontinue Vecuronium (Norcuron) and buspirone (BusPar) ii) Discontinue analgosedation (Precedex/Propofol and Ativan) unless otherwise required for ongoing patient management (no longer required for therapeutic hypothermia) c) Continue to monitor and record core temperature every hour until the patient’s core temperature remains less than or equal to 37.50 C x 24 hours d) If the patient has a core temperature above 37.50 C i) Immediately initiate normothermia protocol 6) Patient management issues a) DVT prophylaxis i) Foot pumps (1) If the patient is fully anticoagulated (INR > 2 or aPTT > 60) do not use foot pumps during therapeutic hypothermia (2) If the patient is not anticoagulated (INR < 2 or aPTT < 60) (a) apply foot pumps (b) administer Lovenox 30 mg or 40 mg subcutaneously daily unless contraindicated b) Nutrition i) May attempt enteral feedings only if the patient’s head can be continuously maintained at or greater than 300 ii) Closely monitor gastric residuals every 2 hours and hold enteral feedings for residuals > 200 ml and restart feedings when residuals are < 100 ml iii) May use gastric motility agents (i.e. metoclopramide [Reglan]) if indicated c) Serum Potassium i) Serum hypokalemia occurs with hypothermia as the potassium moves into the cells. When the patient is re-warmed, the patient’s serum potassium will increase. Aggressive potassium supplementation during hypothermia may result in hyperkalemia when the patient is re-warmed ii) Do not provide potassium supplementation unless: (1) The serum potassium is less than 3.0 mmol/L or (2) Potassium associated cardiac instability iii) If potassium supplementation is provided: (1) Target serum potassium level is 3.5 mmol/L or (2) Until potassium associated cardiac instability is corrected 03.04.2010 9 of 10 Protocol for Therapeutic Hypothermia with Rapr-Round Wraps Medi-Therm III MTA 7900 Modified Bedside Shiver Assessment Scale (mBSAS) 0 – No shiver 1 – MILD = shivering localized to the neck and/or thorax; or fine artifact on cardiac rhythm; or fine artifact on BIS tracing; or unexplained, significant increase in BIS value 2 – MODERATE = shivering involves gross movement of the upper extremities (in addition to neck and thorax) 3 – SEVERE = shivering involves gross movements of the trunk and upper and lower extremities Interventions based on mBSAS 0 – No Shiver Optimize sedation and analgesia Propofol (Diprivan) drip Fentanyl drip Alter shiver threshold Buspirone (BusPar) by gastric tube Vasodilatation Magnesium drip 1 – MILD – all interventions above and ADD Alter shiver threshold Meperidine (Demerol) 12.5 mg IV bolus 2 – MODERATE – all interventions in number 1 above Increase Meperidine (Demerol) to 25 mg IV bolus 3 – SEVERE – all interventions above and ADD Neuromuscular blockade Vecuronium (Norcuron) intermittent boluses 03.04.2010 10 of 10