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The effect of prewarming on hypothermia during orthopaedic surgery and related postoperative complications.

The effect of prewarming on hypothermia during orthopaedic surgery and related postoperative complications. - The effect of prewarming on perioperative hypothermia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34711
Enrollment
100
Registered
2010-05-11
Start date
2010-09-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention for perioperative hypothermia Thermoregulation and cooling

Interventions

2 hours prior to start of the surgery, a novel pre warming intervention will be applied using the Bair Paws® system, which offers active, adjustable warming capabilities in a patient gown allowing p

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)