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Prevention of hypothermia in primary joint replacement patients comparing a conductive blanket with a hot forced air system.


- candidate number27349
- NTR NumberNTR6495
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jun-2017
- Secondary IDsMETCZWH17-049. METC
- Public TitlePrevention of hypothermia in primary joint replacement patients comparing a conductive blanket with a hot forced air system.
- Scientific TitlePrevention of hypothermia in primary joint replacement patients comparing a conductive blanket with a hot forced air system. A randomised non-inferiority study
- ACRONYM
- hypothesisThe conductive blanket is non-inferior to the hot forced air system
- Healt Condition(s) or Problem(s) studiedHypothermia, Joint arthroplasty, Thermoregulation, Bair Hugger
- Inclusion criteria- Planned for primary total hip or knee replacement
- 18 years and older
- Able to speak en write Dutch language
- Agreement of participation after informed consent
- Exclusion criteria- Severe peripheral arterial occlusive disease
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-sep-2017
- Target number of participants90
- InterventionsParticipants receicve either the hot forced air system (Bair Hugger) or the conductive blanket (Barrier Easywarm) during primary joint replacement surgery
- Primary outcomeCore temperature
- Secondary outcomeEar temperature VAS comfort
- TimepointsT(0): pre-operatively on holding
T(1): directly after induction of anesthesiology
T(2): during surgery continious measurement of temperature
T(3): after surgery on recovery
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Paulien van Kampen
- CONTACT for SCIENTIFIC QUERIES Paulien van Kampen
- Sponsor/Initiator Haga Hospital
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryBackground of the study:
Prevention of hypothermia in patients undergoing a primairy Total Knee Prosthesis or Total Hip prosthesis. We want to investigate if the Barrier Easywarm is as effective as with the Forced-Air Warming.

Objective of the study:
If there is comparable Efficacy in preventing hypothermia we can start using the barrier easywarm instead of the BairHugger. With the Bair hugger there is a disruption in airflow in the operation theatre which might bring a higher risk of infection.

Study design:
Randomized Controlled Trial, non inferiority study
Study population:
Patients undergoing total hip or knee prosthesis
Intervention
40 patients will be randomized in the barrier Easywarm group, the other 40 in the Bairhugger group. During the operation the core temperature will be measured by the 3M SpotOn monitoring system

Primary study parameter:
Temperature during operation.
- Main changes (audit trail)
- RECORD6-jun-2017 - 10-jul-2017


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