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

Phase 4

Recruiting

• Conditions: Prevention for perioperative hypothermia; Thermoregulation and cooling; 10043413

• Registration Number: NL-OMON34711
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- Above 18 years of age
- Males and Females
- Scheduled for a major orthopaedic surgery (knee, hip, spine)
- Informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) The occurence and time to hypothermia. Core body temperature registration<br /><br>prior to, during and post surgery<br /><br>2) Skin temperature prior to, during and post surgery (temperature sensor)<br /><br>3) Amount of blood loss peri-operative (including Hb and Ht)<br /><br>4) Established Infection<br /><br>5) Thermal Comfort<br /><br>6) Interventions related to shivering (such as use of pethidine)<br /><br>5) Length of hospitalization stay</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA </p><br>