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Trial · NCT07909252

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of hypothermia on PACU arrivalOnf arrival in the PACU max up to 5 minutes from arrival
Proportion of patients with core temperature \< 36.0 °C measured by zero-heat-flux thermometry (3M SpotOn). Non-inferiority margin for the risk difference (resistive minus forced-air): 7.5 percentage points.
SecondaryCore temperature at end of surgeryAt completion of skin closure up to 10 minutes from skin closureCore temperature (°C) measured by zero-heat-flux thermometry (3M SpotOn).
SecondaryPostoperative shiveringFrom PACU arrival to PACU discharge, assessed every 15 minutes (up to 4 hours)Incidence (BSAS \>= 1) and severity (highest Bedside Shivering Assessment Scale score, 0-3; higher score = more severe shivering).
SecondaryThermal comfortOnce fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrivalPatient-rated 5-point Likert scale (1 = very cold, 2 = cold, 3 = comfortable, 4 = warm, 5 = too hot).
SecondarySubjective feeling of coldOn PACU arrival (if able to respond) and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrivalProportion of patients answering "yes" to the question "Do you feel cold?".
SecondaryObjective signs of thermal discomfortOn PACU arrival and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Proportion of patients with at least one sign of cold discomfort assessed by a blinded observer (piloerection; cold, pale or mottled extremities; shivering; curling up or pulling blankets; request for blankets or warming). Signs of heat discomfort (sweating, flushing, uncovering) are recorded separately.
SecondaryLowest intraoperative core temperatureFrom induction of anaesthesia to end of surgery (assessed during surgery) up to 4 hours from start of the surgeryLowest core temperature (°C) recorded during surgery by zero-heat-flux thermometry.
SecondaryIncidence of intraoperative hypothermiaFrom induction of anaesthesia to end of surgery (assessed during surgery) maximum of 4 hours from start of the surgeryProportion of patients with any core temperature \< 36.0 °C during surgery.
SecondaryCore temperature over timeFrom induction to end of surgery; PACU arrival, 30 minutes after arrival and PACU discharge (up to 4 hours)Core temperature (°C) at 15-minute intervals during surgery and at predefined PACU time points.
SecondaryLength of PACU stayFrom PACU arrival to discharge, up to 24 hoursTime from PACU arrival to PACU discharge (minutes).
SecondaryWarming-related adverse eventsFrom start of warming to PACU discharge (up to 24 hours)Incidence of skin burns, pressure injury at the mattress site, hyperthermia \> 38.0 °C and device malfunction.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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