Prevention for perioperative hypothermia Thermoregulation and cooling
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Above 18 years of age - Males and Females - Scheduled for a major orthopaedic surgery (knee, hip, spine) - Informed consent
Exclusion criteria
Exclusion criteria: - Minor (below the age of 18) or incapacitated subjects -History of diabetic neuropathy or endocrine disorder known to interfere with body temperature regulation. -Vascular disease -Body weight * 36.5 kg. -Obstructive disease of the gastro-intestinal tract, including diverticulitis and inflammatory bowel disease or previous gastrointestinal surgery, except cholecystectomy and appendectomy -Subjects that will undergo a MRI-scan within 2 days after ingestion of the pill (pill should not be in the body anymore) -Cardiac pacemaker or other implanted electromedical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The occurence and time to hypothermia. Core body temperature registration prior to, during and post surgery 2) Skin temperature prior to, during and post surgery (temperature sensor) 3) Amount of blood loss peri-operative (including Hb and Ht) 4) Established Infection 5) Thermal Comfort 6) Interventions related to shivering (such as use of pethidine) 5) Length of hospitalization stay | — |
Countries
Netherlands