The primary objective of the study is to determine whether the use of pre-and intraoperative warming with a forced air technique leads to a reduction of the incidence of hypothermia compared to patients with only intra-operative forced air warming.…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Myocardial disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint is hypothermia defined as a core temperature below 36 *C measured
with SpotOn non-invasive cutaneous thermometer.
Secondary outcome
The delta temperature between the peripheral temperature and core temperature
The delta temperature 15 min after induction and temperature in recovery room
The incidence of peri- and postoperative complications: Blood loss, AKI,
Mortality, Surgical site infection within 30 days PO, Acute Coronary Syndrome,
Myocardial infarction, Indication of re-admission
Length of stay on the recovery and in hospital
Patient satisfaction during stay on the recoveryward
Costs related to the surgical procedure for extended observation, re-admission,
homecare and treatment of complications, occurring within 30 days postoperative
Background summary
Patients undergoing surgery with general anesthesia or local regional
anesthesia will have a decline in body temperature caused by redistribution of
heath from the core compartment to the peripheral compartment. A core
temperature below 36 degrees Celsius is defined as hypothermia. Perioperatieve
hypothermia causes serious complications such as bloodclotting disorders,
surgical site infections, cardiac morbidity and mortality. Recent literature
shows evidence to prevent patients from intra- and postoperative hypothermia
and it*s resulting complications by using forced air prewarming.
Study objective
The primary objective of the study is to determine whether the use of pre-and
intraoperative warming with a forced air technique leads to a reduction of the
incidence of hypothermia compared to patients with only intra-operative forced
air warming. Secondary objectives are the incidence of intra- and postoperative
complications and cost effectiveness of implementing forced air prewarming.
Study design
Prospective randomized controlled trail. Patients will be randomized to the
intervention group: 30min of prewarming with forces air technique in the
preoperative holding and the control group: intra operative forced air warming
(standardcare).
Intervention
Patients in the forced air warming group will be prewarmed, 20-30 minutes
preoperatively, in the preoperative waiting room area, using a Bair Paws gown
and Bairhugger warming unit for 30 minutes. Prewarming will be stopped if
patients core temperature rizes above 37.5 degrees Celsius. Intra operative,
warming with forced air technique will be continued according to our local
standards . In addition, patients will be administered prewarmed intravenous
fluids by using an active fluid warmer
Study burden and risks
Due to the observational nature of this study there are no side effects to be
expected. The use of the SpotOn non invasive cutaneous thermometer is expected
to be safe in patients under general anesthesia or spinal anesthesia. The use
of forced air prewarming with Bairhugger is expected to be safe, there is no
risk of burn wounds when used according to the manufacturers manual. Pre
warming will be stopped if patients core temperature rises above 37,5 C.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
1) Patients 18 years and older
2) elective orthopedic surgery: total knee arthroplasty and total hip arthroplasty
3) Patients classified ASA I, II or III
Exclusion criteria
1) Patients younger than 18 years
2) Surgery < 60 minutes
3) Patients admitted for day care surgery
4) Patients undergoing emergent surgery
5) Other surgery than total knee- and hip arthroplasty
6) ASA IV of V
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52209.100.15 |
| OMON | NL-OMON22080 |