|- candidate number||23995|
|- NTR Number||NTR5754|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2016|
|- Secondary IDs||NL52209.100.15 WO 14.078|
|- Public Title||Effectiveness of Forced Air Preoperative warming|
|- Scientific Title||Effectiveness of Forced Air Preoperative warming|
|- ACRONYM||FAP study|
|- hypothesis||The use of preoperative warming of patients undergoing total hip- or knee arthroplasty with a forced air technique will reduce the incidence of postoperative hypothermia. |
|- Healt Condition(s) or Problem(s) studied||Postoperative hypothermia |
|- Inclusion criteria||- >18y|
- Patients scheduled for total knee – and total hip arthroplasty
- ASA I, II or III
|- Exclusion criteria||- < 18y|
- Surgery < 60 minutes
- Day care surgery
- Surgical Emergency
- Other surgery than total knee – and total hip arthroplasty
- ASA IV or V
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-jan-2016|
|- planned closingdate||31-dec-2016|
|- Target number of participants||222|
|- Interventions||Patients in the FAP group will be prewarmed, 30 minutes preoperatively, in the preoperative waiting room, using a ®Bair Paws gown for 30 minutes. The ®Bair Paws perioperative single use patient gown (Arizant Healthcare, UK) is a gown developed for perioperative skin surface warming. The gown will be connected via corrugated hose to a ®Bair Hugger warming unit to provide intraoperative warming. The temperature output of the device is set on a temperature and 43 Celsius. Temperature output can be adjusted according to the patient needs.
Patients in the standard care group will receive 30 minutes preoperatively a disposable heated blanket in the preoperative waiting room area. Intra-operative a forced air warming with ®Bair Paws gown will be applied. The ®Bair Paws perioperative single use patient gown (Arizant Healthcare, UK) is a gown developed for perioperative skin surface warming. The gown will be connected via corrugated hose to a ®Bair Hugger warming unit to provide intraoperative warming. The temperature output of the device is set on a temperature and 43 degrees Celsius. Temperature output can be adjusted according to the patient needs. Furthermore administered iv fluids will be warmed by an active fluid warmer (enFlow®IV Fluid Warmer, Vital Signs A GE Healthcare company).
|- Primary outcome||The primary endpoint of this study is the percentage of postoperative hypothermic patients with temperature below 36 degrees Celsius measured during entrance of the OR, 15 min after induction of anaesthesia and on the recovery room at first temperature.|
|- 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 PACU and in hospital
-Patient satisfaction during stay on the PACU.
-Costs related to the surgical procedure for extended observation, re-admission, homecare and treatment of complications, occurring within 30 days postoperative. To obtain these data e ill intervie patients by t
telephone 0 day’s postoperative.
|- Timepoints||-30 minutes preoperative|
-postoperative during stay on PACU
-30 day's postoperative
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.A.M. Siepel|
|- CONTACT for SCIENTIFIC QUERIES|| M.A.M. Siepel|
|- Sponsor/Initiator ||Onze Lieve Vrouwe Gasthuis (OLVG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: 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. Intra- and postoperative hypothermia causes serious complications such as blood clotting 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 before surgery (so called prewarming),in stead of forced air warming only during surgery (standard care)|
Objective: The primary objective of the study is to determine whether the use of preoperative warming with a forced air technique leads to a reduction of the incidence of hypothermia compared to patients with standard care. 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 in the preoperative holding and the control group: standard preoperative care.
Study population: Eligible patients are patients undergoing orthopaedic surgery for total knee – and hip arthroplasty.
Intervention (if applicable): 30 minutes preoperative warming with forced air technique (FAP) by using the ®Bair Paws gown and ®Bairhugger warming unit.
Main study parameters/endpoints: ain endpoint is hypothermia defined as a core temperature belo elsius measured with ®SpotOn non-invasive cutaneous thermometer.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Due to the observational nature of this study there are no side effects to be expected. The use of the ®SpotOn non invasive thermometer, measuring core temperature, is expected to be safe in patients under general anaesthesia or spinal anaesthesia. Measuring core temperature with ®Spot-On thermometer is a validated method, proven by literature. The use of forced air rewarming with ®Bair Paws gown and ®Bairhugger warming unit is expected to be safe.
|- Main changes (audit trail)|
|- RECORD||19-feb-2016 - 22-mei-2016|