Perioperative HypothermiaWARM-NINCT07909252
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
A study testing Forced-air warming and Resistive conductive warming in people with Perioperative Hypothermia and Inadvertent Perioperative Hypothermia, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
Perioperative hypothermia (core temperature below 36.0 °C) is a common complication of surgery and is associated with increased blood loss, wound infection, cardiovascular events and patient discomfort. Forced-air warming (Bair Hugger) is the standard method of active warming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hypothermia, Inadvertent Perioperative Hypothermia, Hypothermia
- What is being tested?
- Forced-air warming and Resistive conductive warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Elective surgery under general anaesthesia, any type of surgery, surgical approach and duration
- ASA physical status I-III
- Written informed consent
Who cannot join
- Emergency surgery
- General anaesthesia combined with neuraxial block (spinal or epidural)
- Preoperative core temperature below 36.0 °C or above 38.0 °C
- Sepsis
- Body mass index below 18 or above 35 kg/m2
- Known thermoregulatory disorder or significant endocrine disease affecting thermoregulation (e.g., severe thyroid disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
Masaryk Hospital in Usti nad Labem
Ústí nad Labem, 400 11
Michal Kalina, MD, PhD, MBA, +420773628756, michal.kalina@kzcr.eu
About this study
Official title: Resistive Conductive Warming (HotDog) Versus Forced-Air Warming (Bair Hugger) for Prevention of Perioperative Hypothermia in Elective Surgery Under General Anaesthesia: a Single-Centre Randomised Controlled Non-Inferiority Trial
Perioperative hypothermia (core temperature below 36.0 °C) is a common complication of surgery and is associated with increased blood loss, wound infection, cardiovascular events and patient discomfort. Forced-air warming (Bair Hugger) is the standard method of active warming. Resistive conductive warming (HotDog) transfers heat by direct contact and does not blow air into the operating room, which may be advantageous. This randomised trial will test whether resistive warming is not inferior to forced-air warming in preventing hypothermia on arrival in the post-anaesthesia care unit (PACU) in adults undergoing elective surgery under general anaesthesia.
Read the detailed description
Design: single-centre, prospective, randomised, controlled, parallel-group non-inferiority trial with 1:1 allocation, reported according to CONSORT and its extension for non-inferiority trials.
Randomisation: computer-generated block randomisation (random blocks of 4 and 6) using StudyRandomizer, stratified by type of surgery (laparoscopic/endoscopic in a body cavity; open body-cavity surgery; other procedures). Allocation is revealed only after eligibility is confirmed and written informed consent is obtained.
Interventions: all patients receive passive insulation with a reflective (silver) blanket from arrival in the pre-operative area until induction and during transfer to the PACU. After induction of general anaesthesia, patients receive active warming with either forced-air warming (Bair Hugger, upper- or lower-body blanket, 43 °C) or resistive conductive warming (HotDog, underbody mattress, 42 °C) until the end of surgery. Anaesthesia, fluids and operating-room temperature follow standard institutional practice and are recorded. If core temperature falls below 35.5 °C, the anaesthetist may add rescue warming; this is recorded as a protocol deviation. Duration of surgery is not restricted and is recorded.
Temperature measurement: core temperature is measured non-invasively with a zero-heat-flux sensor (3M SpotOn) placed on the forehead before induction and kept in place until the PACU; values are recorded at baseline, every 15 minutes during surgery, at the end of surgery, within 5 minutes of PACU arrival, 30 minutes after arrival and at PACU discharge.
PACU assessments: shivering (Bedside Shivering Assessment Scale), thermal comfort (5-point Likert scale), subjective feeling of cold ("Do you feel cold?") and objective signs of thermal discomfort (piloerection; cold, pale or mottled extremities; shivering; curling up; request for blankets; sweating; flushing; uncovering).
Blinding: operating-room staff cannot be blinded. Warming devices remain in the operating room and the PACU outcome assessor is blinded: PACU assessments are performed by staff not involved in intraoperative care and unaware of group allocation. Statistical analysis is performed with coded groups.
Sample size: assuming a hypothermia incidence of 12.5% in both groups, a non-inferiority margin of 7.5 percentage points, one-sided alpha 0.025 and 80% power, 305 patients per group are required; with 10% dropout, 340 patients per group (680 in total) will be enrolled.
Statistical analysis: the primary outcome is analysed as the risk difference (HotDog minus Bair Hugger) with a two-sided 95% confidence interval (Newcombe method). Non-inferiority is concluded if the upper limit is below 7.5 percentage points in both the intention-to-treat and per-protocol populations. If non-inferiority is shown, superiority is tested hierarchically. Sensitivity analyses include a stratum-adjusted (Mantel-Haenszel) risk difference and logistic regression adjusted for stratum, age, BMI, duration of surgery and operating-room temperature. Temperature over time is analysed with a linear mixed model. Secondary outcomes are exploratory.
- Being tested
- Forced-air warming, Resistive conductive warming
- Keywords
- forced-air warming, resistive warming, conductive warming, patient warming, Bair Hugger, HotDog, zero-heat-flux thermometry, postoperative shivering, thermal comfort, general anaesthesia, non-inferiority
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced-air warmingDevice
Also called Bair Hugger
Convective active warming system blowing warmed air through a disposable upper- or lower-body blanket (Bair Hugger, Solventum, formerly 3M), set to 43 °C, from induction of anaesthesia until the end of surgery.
Resistive conductive warmingDevice
Also called HotDog
Air-free resistive polymer warming mattress placed under the patient, transferring heat by direct contact (HotDog, Augustine Surgical), set to 42 °C, from induction of anaesthesia until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Forced-air warming (Bair Hugger) | Active comparator | Forced-air warming with a Bair Hugger upper- or lower-body blanket (according to surgical site), set to 43 °C, started immediately after induction of general anaesthesia and continued until the end of surgery. Passive reflective-blanket insulation before induction and during transfer to PACU. Receives: Device: Forced-air warming |
| Resistive warming (HotDog) | Experimental | Resistive conductive warming with a HotDog underbody mattress, set to 42 °C, started immediately after induction of general anaesthesia and continued until the end of surgery. Passive reflective-blanket insulation before induction and during transfer to PACU. Receives: Device: Resistive conductive warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypothermia on PACU 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.
Measured: Onf arrival in the PACU max up to 5 minutes from arrival
Secondary outcomes (10)
Core temperature at end of surgery
Core temperature (°C) measured by zero-heat-flux thermometry (3M SpotOn).
Measured: At completion of skin closure up to 10 minutes from skin closure
Postoperative shivering
Incidence (BSAS >= 1) and severity (highest Bedside Shivering Assessment Scale score, 0-3; higher score = more severe shivering).
Measured: From PACU arrival to PACU discharge, assessed every 15 minutes (up to 4 hours)
Thermal comfort
Patient-rated 5-point Likert scale (1 = very cold, 2 = cold, 3 = comfortable, 4 = warm, 5 = too hot).
Measured: Once fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Subjective feeling of cold
Proportion of patients answering "yes" to the question "Do you feel cold?".
Measured: On PACU arrival (if able to respond) and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Objective signs of thermal discomfort
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.
Measured: On PACU arrival and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Lowest intraoperative core temperature
Lowest core temperature (°C) recorded during surgery by zero-heat-flux thermometry.
Measured: From induction of anaesthesia to end of surgery (assessed during surgery) up to 4 hours from start of the surgery
Incidence of intraoperative hypothermia
Proportion of patients with any core temperature < 36.0 °C during surgery.
Measured: From induction of anaesthesia to end of surgery (assessed during surgery) maximum of 4 hours from start of the surgery
Core temperature over time
Core temperature (°C) at 15-minute intervals during surgery and at predefined PACU time points.
Measured: From induction to end of surgery; PACU arrival, 30 minutes after arrival and PACU discharge (up to 4 hours)
Length of PACU stay
Time from PACU arrival to PACU discharge (minutes).
Measured: From PACU arrival to discharge, up to 24 hours
Warming-related adverse events
Incidence of skin burns, pressure injury at the mattress site, hyperthermia > 38.0 °C and device malfunction.
Measured: From start of warming to PACU discharge (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perioperative HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised 1:1 parallel-group non-inferiority trial, stratified by type of surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Faculty of Medicine in Hradec Kralove, Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies
- Responsible party
- Sponsor
- Investigators
- Michal Kalina, MD, PhD, MBA, Principal investigator, Krajska zdravotni, a.s., Masaryk Hospital in Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909252
- Sponsor's protocol ID
- KZ-KAPIM-HYPOTERM-2026
- Acronym
- WARM-NI
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregated results will be published in a peer-reviewed journal.
Publications
Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.
PubMed 27098439Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126Wongyingsinn M, Pookprayoon V. Incidence and associated factors of perioperative hypothermia in adult patients at a university-based, tertiary care hospital in Thailand. BMC Anesthesiol. 2023 Apr 25;23(1):137. doi: 10.1186/s12871-023-02084-2.
PubMed 37098492Okgun Alcan A, Aygun H, Kurt C. Resistive Warming Mattress, Forced-Air Warming System, or a Combination of the Two in the Prevention of Intraoperative Inadvertent Hypothermia: A Randomized Trial. J Perianesth Nurs. 2023 Aug;38(4):611-615. doi: 10.1016/j.jopan.2022.11.007. Epub 2023 Apr 6.
PubMed 37031060Sandoval MF, Mongan PD, Dayton MR, Hogan CA. Safety and efficacy of resistive polymer versus forced air warming in total joint surgery. Patient Saf Surg. 2017 Apr 14;11:11. doi: 10.1186/s13037-017-0126-0. eCollection 2017.
PubMed 28416968John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
PubMed 26787794Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
PubMed 20042442
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistive Conductive Warming (HotDog) Versus Forced-Air Warming (Bair Hugger) for Prevention of Perioperative Hypothermia in Elective Surgery Under General Anaesthesia: a Single-Centre Randomised Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07909252
- Acronym / sponsor ID
- WARM-NI / KZ-KAPIM-HYPOTERM-2026
- Keywords
- forced-air warming, resistive warming, conductive warming, patient warming, Bair Hugger, HotDog, zero-heat-flux thermometry, postoperative shivering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Collaborators
- Charles University, Faculty of Medicine in Hradec Kralove, Jan Evangelista Purkyne University in Usti nad Labem, Faculty of Health Studies
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative hypothermia (core temperature below 36.0 °C) is a common complication of surgery and is associated with increased blood loss, wound infection, cardiovascular events and patient discomfort. Forced-air warming (Bair Hugger) is the standard method of active warming. Resistive conductive warming (HotDog) transfers heat by direct contact and does not blow air into the operating room, which may be advantageous. This randomised trial will test whether resistive warming is not inferior to forced-air warming in preventing hypothermia on arrival in the post-anaesthesia care unit (PACU) in adults undergoing elective surgery under general anaesthesia.
Detailed description
Design: single-centre, prospective, randomised, controlled, parallel-group non-inferiority trial with 1:1 allocation, reported according to CONSORT and its extension for non-inferiority trials.
Randomisation: computer-generated block randomisation (random blocks of 4 and 6) using StudyRandomizer, stratified by type of surgery (laparoscopic/endoscopic in a body cavity; open body-cavity surgery; other procedures). Allocation is revealed only after eligibility is confirmed and written informed consent is obtained.
Interventions: all patients receive passive insulation with a reflective (silver) blanket from arrival in the pre-operative area until induction and during transfer to the PACU. After induction of general anaesthesia, patients receive active warming with either forced-air warming (Bair Hugger, upper- or lower-body blanket, 43 °C) or resistive conductive warming (HotDog, underbody mattress, 42 °C) until the end of surgery. Anaesthesia, fluids and operating-room temperature follow standard institutional practice and are recorded. If core temperature falls below 35.5 °C, the anaesthetist may add rescue warming; this is recorded as a protocol deviation. Duration of surgery is not restricted and is recorded.
Temperature measurement: core temperature is measured non-invasively with a zero-heat-flux sensor (3M SpotOn) placed on the forehead before induction and kept in place until the PACU; values are recorded at baseline, every 15 minutes during surgery, at the end of surgery, within 5 minutes of PACU arrival, 30 minutes after arrival and at PACU discharge.
PACU assessments: shivering (Bedside Shivering Assessment Scale), thermal comfort (5-point Likert scale), subjective feeling of cold ("Do you feel cold?") and objective signs of thermal discomfort (piloerection; cold, pale or mottled extremities; shivering; curling up; request for blankets; sweating; flushing; uncovering).
Blinding: operating-room staff cannot be blinded. Warming devices remain in the operating room and the PACU outcome assessor is blinded: PACU assessments are performed by staff not involved in intraoperative care and unaware of group allocation. Statistical analysis is performed with coded groups.
Sample size: assuming a hypothermia incidence of 12.5% in both groups, a non-inferiority margin of 7.5 percentage points, one-sided alpha 0.025 and 80% power, 305 patients per group are required; with 10% dropout, 340 patients per group (680 in total) will be enrolled.
Statistical analysis: the primary outcome is analysed as the risk difference (HotDog minus Bair Hugger) with a two-sided 95% confidence interval (Newcombe method). Non-inferiority is concluded if the upper limit is below 7.5 percentage points in both the intention-to-treat and per-protocol populations. If non-inferiority is shown, superiority is tested hierarchically. Sensitivity analyses include a stratum-adjusted (Mantel-Haenszel) risk difference and logistic regression adjusted for stratum, age, BMI, duration of surgery and operating-room temperature. Temperature over time is analysed with a linear mixed model. Secondary outcomes are exploratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised 1:1 parallel-group non-inferiority trial, stratified by type of surgery.
| Arm | Type | Receives |
|---|---|---|
| Forced-air warming (Bair Hugger) | Active comparator | Device: Forced-air warmingForced-air warming with a Bair Hugger upper- or lower-body blanket (according to surgical site), set to 43 °C, started immediately after induction of general anaesthesia and continued until the end of surgery. Passive reflective-blanket insulation before induction and during transfer to PACU. |
| Resistive warming (HotDog) | Experimental | Device: Resistive conductive warmingResistive conductive warming with a HotDog underbody mattress, set to 42 °C, started immediately after induction of general anaesthesia and continued until the end of surgery. Passive reflective-blanket insulation before induction and during transfer to PACU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Elective surgery under general anaesthesia, any type of surgery, surgical approach and duration
- ASA physical status I-III
- Written informed consent
Key exclusion criteria (6 listed)
- Emergency surgery
- General anaesthesia combined with neuraxial block (spinal or epidural)
- Preoperative core temperature below 36.0 °C or above 38.0 °C
- Sepsis
- Body mass index below 18 or above 35 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forced-air warmingAlso: Bair HuggerConvective active warming system blowing warmed air through a disposable upper- or lower-body blanket (Bair Hugger, Solventum, formerly 3M), set to 43 °C, from induction of anaesthesia until the end of surgery. | Device | Forced-air warming (Bair Hugger) |
| Resistive conductive warmingAlso: HotDogAir-free resistive polymer warming mattress placed under the patient, transferring heat by direct contact (HotDog, Augustine Surgical), set to 42 °C, from induction of anaesthesia until the end of surgery. | Device | Resistive warming (HotDog) |
Primary outcome
Incidence of hypothermia on PACU arrival
Time frame: Onf 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.
10 secondary outcomes
Core temperature at end of surgery
Time frame: At completion of skin closure up to 10 minutes from skin closure
Postoperative shivering
Time frame: From PACU arrival to PACU discharge, assessed every 15 minutes (up to 4 hours)
Thermal comfort
Time frame: Once fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Subjective feeling of cold
Time frame: On PACU arrival (if able to respond) and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Objective signs of thermal discomfort
Time frame: On PACU arrival and when fully oriented in PACU (Aldrete score >= 9), up to 4 hours after arrival
Lowest intraoperative core temperature
Time frame: From induction of anaesthesia to end of surgery (assessed during surgery) up to 4 hours from start of the surgery
Incidence of intraoperative hypothermia
Time frame: From induction of anaesthesia to end of surgery (assessed during surgery) maximum of 4 hours from start of the surgery
Core temperature over time
Time frame: From induction to end of surgery; PACU arrival, 30 minutes after arrival and PACU discharge (up to 4 hours)
Length of PACU stay
Time frame: From PACU arrival to discharge, up to 24 hours
Warming-related adverse events
Time frame: From start of warming to PACU discharge (up to 24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 27098439Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- Background: PubMed 37098492Wongyingsinn M, Pookprayoon V. Incidence and associated factors of perioperative hypothermia in adult patients at a university-based, tertiary care hospital in Thailand. BMC Anesthesiol. 2023 Apr 25;23(1):137. doi: 10.1186/s12871-023-02084-2.
- Background: PubMed 37031060Okgun Alcan A, Aygun H, Kurt C. Resistive Warming Mattress, Forced-Air Warming System, or a Combination of the Two in the Prevention of Intraoperative Inadvertent Hypothermia: A Randomized Trial. J Perianesth Nurs. 2023 Aug;38(4):611-615. doi: 10.1016/j.jopan.2022.11.007. Epub 2023 Apr 6.
- Background: PubMed 28416968Sandoval MF, Mongan PD, Dayton MR, Hogan CA. Safety and efficacy of resistive polymer versus forced air warming in total joint surgery. Patient Saf Surg. 2017 Apr 14;11:11. doi: 10.1186/s13037-017-0126-0. eCollection 2017.
- Background: PubMed 26787794John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
- Background: PubMed 20042442Brandt S, Oguz R, Huttner H, Waglechner G, Chiari A, Greif R, Kurz A, Kimberger O. Resistive-polymer versus forced-air warming: comparable efficacy in orthopedic patients. Anesth Analg. 2010 Mar 1;110(3):834-8. doi: 10.1213/ANE.0b013e3181cb3f5f. Epub 2009 Dec 30.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregated results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Kalina, MD, PhD, MBA principal investigator
Krajska zdravotni, a.s., Masaryk Hospital in Usti nad Labem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced-air warming and Resistive conductive warming in people with Perioperative Hypothermia and Inadvertent Perioperative Hypothermia, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Kalina, MD, PhD, MBA (+420773628756, michal.kalina@kzcr.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypothermia on PACU arrival (time frame: Onf arrival in the PACU max up to 5 minutes from arrival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07909252, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.