CompletedNot Applicable

Thermal Insulation System in Inadvertent Hypothermia

Portugal124 participantsStarted 2018-10-15

Plain-language summary

This study compares the effectiveness of a new layered thermal insulation system (SIT-3c) versus the traditional thermal body protection (warmed forced air system) for patients under total knee arthroplasty, during the intra-operative phase.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged over 18 years, with the diagnosis of gonarthrosis, to undergo total elective knee arthroplasty, under neuroaxial anesthesia, who agreed to participate in the study. Exclusion Criteria: * With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy

What they're measuring

Changes in tympanic temperature (T1)

Timeframe: Baseline (entrance in the operating room)

Changes in tympanic temperature (T2)

Timeframe: immediately after anesthesia

Changes in tympanic temperature (T3)

Timeframe: 15 minutes after beginning surgery

Changes in tympanic temperature (T4)

Timeframe: 30 minutes after beginning surgery

Changes in tympanic temperature (T5)

Timeframe: 45 minutes after beginning surgery

Changes in tympanic temperature (T6)

Timeframe: Up to 10 min after the end of surgery (living the operating room)

Changes in shivering (T1)

Timeframe: Baseline (entrance in the operating room)

Changes in shivering (T2)

Timeframe: immediately after anesthesia

Trial details

NCT IDNCT05131568

SponsorUniversidade do Porto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-30

View on ClinicalTrials.gov More Perioperative Hypothermia trials