S.D. Paramedic NEWS-ONLINE

updated 01-20-97

Protocol Sumary

On 01/14/97 Angie Mendoza of the EMSA office advised Mel Ochs, M.D., F.A.C.E.P. (Medical Director, County of San Diego, Department of Health Services, Division of Emergency Medical Services) that we have been officially approved by the State of California E.M.S. Authority for the San Diego County PreHospital RSI study and that the letter confirming this will be sent immediately. She was advised that we intended to begin the study as soon as possible and that our projected timeline was to begin 1 July. But, if it would be too disrupted by the transition to the new paramedic provider for the City of San Diego on that date, the implementation date would move back to 1 September.

Committees have been actively working on the training and implementation programs. We are official!

Doctor Ochs would like the thank you all for your help so far and of course, your support in the future!

• Protocol Title:

  Neuromuscular Blocking Agent Used by Field Paramedics in Endo tracheal Intubation of Trauma Patients with Glasscow Coma Scores of 8 or less.

  
  
• Study Objectives:

  Evaluate decrease in hypoxia-mediated secondary brain injury and improvement in success rates of intubations.

  
  
• Primary Endpoints:

  pO2 on arrival at Trauma Center.

  pH on arrival at Trauma Center.

  In-house complications during the first 30 days.

  Glassgow Outcome Score at discharge, 3 months and 6 months.

  Mortality.

  
  
• Subject Population:

  All adult trauma patients with Glasgow Coma Score of 8 or less.
  
  

  
  
• Patient Inclusion:

  Trauma Center candidate

  Suspected head injury

  18 years old or over (research candidate criteria)

  Glasgow Coma Scale of 8 or less

  Transport time to a Trauma Center Suite of more than 10 min from the time of the beginning of the procedure

  Combitube backup airway

  
  
• Patient Evaluation

  Pupil exam

  Extremity movement

  Glasgow Coma Scale evaluation

  
  
• Study Design:

  Prospective, case controlled.

  
  
• Study Medications:

  Midazolam (Versed), 5 mg/ml, 2 ml vials.
  Amnesic and sedative effect
  
  

  Succinylcholine (Anectine), 20 mg/ml, 10 ml vials.
  Short acting depolarizing neuromuscular blocking agent
  
  

  Rocuronium (Zemuron), 10 mg/ml, 5 ml vials.
  Moderate duration non-depolarizing neuromuscular blocking agent
  
  

  Morphine Sulfate (MSO 4), 10 mg/2ml.
  Stress relieving post procedure response
  
  

  
  
• Dosage form:

  Sterile solution

  
  
• Dosages:

  Patient Weight	Small 35-63 Kg 80-140 lbs.	Average 63-100 Kg 141-225 lbs.	Large > 100 Kg > 225 lbs.
  VERSED may repeat Q 30 min	2 mg = 0.4 cc 1 mg = 0.2 cc	2.5 mg = 0.5 cc 1 mg = 0.2 cc	3 mg = 0.6 cc 1 mg = 0.2 cc
  Succinylcholine may repeat X 1 only	80 mg = 4.0 cc	120 mg = 6.0 cc	160 mg = 8.0 cc
  Rocuronium May repeat prm	40 mg = 4.0 cc 10 mg = 1.0 cc	60 mg = 6.0 cc 15 mg = 1.5 cc	80 mg = 8.0 cc 20 mg = 2.0 cc
  MSO4 Repeat Q 3 min for BP > 160 and HR > 90	2 mg	2 mg	2 mg

  
  
• Route of Administration:

  Intravenous.

  
  
• Dose and Regimen

  Midazolam, 3-5 mg IV for induction/amnesic effect if necessary, pre intubation.

  Succinylcholine, 80mg -160 mg IV (weight related dose) prior to intubation.

  Rocuronium, 40 mg-80 mg IV (weight related dose) following sucessful intubation; repeated doses at 10 mg - 20 mg IV as needed for maintenance.

  Morphine Sulfate, mg IV, after intubation, for hypertensive stress response if heart rate is great than 90/minute and BP is greater than 160 systolic. May be repeated every 3 minutes.

  
  
• Duration of treatment:

  During field treatment and transport to trauma center.

  
  
• Duration of Subject Participation in Study:

  Final Glascow Outcome Score at 6 months.

  
  
• Number of Evaluable Subjects Required to Meet Protocol Objective:

  100 patients.

  
  
• Number of Trauma Centers:

  5 Trauma Centers.

  
  
• Number of Patients per Center:

  10 - 20 per year.

  
  

Contact the county medical director: Send E-Mail to: Mel Ochs, M.D., F.A.C.E.P. Medical Director, County of San Diego, Department of Health Services, Division of Emergency Medical Services.

Send E-Mail to: The San Diego Paramedics.

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