title: Safety and performance of a novel intravascular catheter for induction and reversal of hypothermia in a porcine model.
abstract: OBJECTIVE
  This study was undertaken to assess the acute safety and feasibility of rapidly inducing, maintaining, then reversing hypothermia using a novel heat transfer catheter and a closed-loop automatic feedback temperature control system to overcome limitations imposed by current clinical practices used for perioperative cooling and warming.
  
  
  METHODS
  Six swine (mean mass, 53.8 +/- 3.6 kg) were studied. The heat transfer catheter was placed in the inferior vena cava via the femoral vein. Hypothermia to 32 degrees C was induced, maintained for 6 hours, then reversed to 36 degrees C. The time needed to induce and reverse hypothermia was recorded via continuous temperature monitoring of the lower esophagus, cerebrum, and rectum. Electrocardiography provided continuous monitoring, and blood draws were made at baseline and at 2-hour intervals. Examination of the catheter in situ was performed after the animals were killed.
  
  
  RESULTS
  Cooling from 36.2 to 32.0 degrees C was rapid and uniform (mean, 7.3 +/- 0.7 degrees C/h), with animals reaching the target temperature within 60 minutes. Rewarming was also easily controlled, with animals' temperatures reaching 36 degrees C within 130 minutes. No arrhythmia was observed, and all hematological variables were within the normal range for swine. There was no evidence of hemolysis or platelet changes. Little to no thrombosis was observed.
  
  
  CONCLUSIONS
  The data presented here suggest that rapid induction and reversal of hypothermia are technically possible using a core intravenous cooling catheter; this method would provide a safe, rapid, and exquisitely reproducible way to induce hypothermia with subsequent restoration of normothermia.
authors.affiliation: Innercool Therapies, Inc., San Diego, California 92121, USA. beckyi@innercool.com
authors.forename: Becky
authors.initials: B
authors.lastname: Inderbitzen
authors.forename: Steven
authors.initials: S
authors.lastname: Yon
authors.forename: Juan
authors.initials: J
authors.lastname: Lasheras
authors.forename: John
authors.initials: J
authors.lastname: Dobak
authors.forename: John
authors.initials: J
authors.lastname: Perl
authors.forename: Gary K
authors.initials: GK
authors.lastname: Steinberg
mesh_terms: D000818:Animals; D001833:Body Temperature Regulation; D002408:Catheters, Indwelling; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D007036:Hypothermia, Induced / Q000295:instrumentation*; D017694:Rewarming / Q000295:instrumentation*; D013552:Swine