Perioperative HypothermiaSIT-3cNCT05131568
Thermal Insulation System in Inadvertent Hypothermia
A study testing Layered thermal insulation system in people with Perioperative Hypothermia, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Hypothermia
- What is being tested?
- Layered thermal insulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Oct 2018to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Porto - Biomedical Sciences Institut
Porto, 4050-313
About this study
Official title: Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort
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.
Read the detailed description
Protecting patients from the cold in the operating room is a complex problem that has encouraged the search for better and more effective thermal protection systems. Some disadvantages have been observed in the daily use of the recommended thermal protection system (forced warm air).
This study intends to design and evaluate the effectiveness of a three-layer thermal insulation system, comparing its effect with the forced warm air system on temperature variation, shivering incidence and comfort perception, in patients undergoing total knee arthroplasty under neuro-axial anesthesia, during the intra-operative phase.
Participants are randomly assigned to the experimental group (EG) or control group (CG). The experimental group receives as a skin protection the three-layer thermal insulation system (SIT-3c) and the control group receives the usual recommended system (forced warm air).
Both systems are placed at the entrance to the operating room and held on patients during the entire intra-operative phase.
- Conditions
- Perioperative Hypothermia
- Being tested
- Layered thermal insulation system
- Keywords
- perioperative hypothermia, thermal insulation, perioperative comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Layered thermal insulation systemDevice
No other intervention
| Study group | Role | What they receive |
|---|---|---|
| Thermal insulation system | Experimental | experimental: layered thermal insulation system
The system was applied in the upper body to the entrance of the operating room and remained until the exit of the same room.
The test included the evaluation of temperature, tremors and the visual perception of thermal comfort in 6 moments (T1 - reference temperature - at the entrance of the anesthetic induction room, T2 - at the entrance to the operating room, T3, T4 and T5 - fifteen , thirty and forty-five minutes after the start of surgery, and T6 - leaving the operating room) Receives: Device: Layered thermal insulation system |
| Forced air active warming | No intervention | Control: the same procedures as in the experiment group, were carried out in the control group, except for the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tympanic temperature (T1)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: Baseline (entrance in the operating room)
Changes in tympanic temperature (T2)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: immediately after anesthesia
Changes in tympanic temperature (T3)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: 15 minutes after beginning surgery
Changes in tympanic temperature (T4)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: 30 minutes after beginning surgery
Changes in tympanic temperature (T5)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: 45 minutes after beginning surgery
Changes in tympanic temperature (T6)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Measured: Up to 10 min after the end of surgery (living the operating room)
Changes in shivering (T1)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: Baseline (entrance in the operating room)
Changes in shivering (T2)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: immediately after anesthesia
Changes in shivering (T3)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: 15 minutes after beginning surgery
Changes in shivering (T4)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: 30 minutes after beginning surgery
Changes in shivering (T5)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: 45 minutes after beginning surgery
Changes in shivering (T6)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Measured: Up to 10 min after the end of surgery (living the operating room)
Changes in visual perception of Thermal comfort (T1)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: Baseline (entrance in the operating room)
Changes in visual perception of Thermal comfort (T2)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: immediately after anesthesia
Changes in visual perception of Thermal comfort (T3)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: 15 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T4)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: 30 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T5)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: 45 minutes after beginning surgery
Changes in visual perception of Thermal comfort (T6)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Measured: Up to 10 min after the end of surgery (living the operating room)
Secondary outcomes (3)
General intraoperative comfort
Method of assessment - the Perioperative Comfort Scale, based on Kolcaba´s theory, composed of 15 items answered by a six-point Likert scale ranging from 1 (totally disagree) to 6 (I totally agree), which measures general aspects of comfort in three dimensions: relief, ease and transcendence.
Measured: 30 minutes after beginning surgery
Thermal intraoperative comfort
Method of assessment - the Thermal Comfort Scale, composed of 9 items answered by a six-point Likert scale ranging from 1 (totally disagree) to 6 (I totally agree), which measures thermal aspects of comfort in two dimensions: physical and emotional.
Measured: 30 minutes after beginning surgery
Ergonomic comfort
Method of assessment - the Ergonomic questionnaire, composed of 10 items answered by a five-point Likert scale ranging from 1 (not at all comfortable) to 5 (very comfortable).
Measured: 30 minutes after beginning surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start15 Oct 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaura Carvalho, Dr., Principal investigator, Hospital of Prelada - Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131568
- Sponsor's protocol ID
- SIT-3c
- Acronym
- SIT-3c
- Status last verified
- Sep 2018
- First submitted
- 18 Oct 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AORN Recommended Practices Committee. Recommended practices for the prevention of unplanned perioperative hypothermia. AORN J. 2007 May;85(5):972-4, 976-84, 986-8. doi: 10.1016/j.aorn.2007.04.015. No abstract available.
PubMed 17533677Fallis WM, Hamelin K, Symonds J, Wang X. Maternal and newborn outcomes related to maternal warming during cesarean delivery. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):324-31. doi: 10.1111/j.1552-6909.2006.00052.x.
PubMed 16700681Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Frank SM, El-Rahmany HK, Cattaneo CG, Barnes RA. Predictors of hypothermia during spinal anesthesia. Anesthesiology. 2000 May;92(5):1330-4. doi: 10.1097/00000542-200005000-00022.
PubMed 10781278Koeter M, Leijtens B, Koeter S. Effect of thermal reflective blanket placement on hypothermia in primary unilateral total hip or knee arthroplasty. J Perianesth Nurs. 2013 Dec;28(6):347-52. doi: 10.1016/j.jopan.2012.08.007.
PubMed 24267622Kurz A, Sessler DI, Narzt E, Lenhardt R, Lackner F. Morphometric influences on intraoperative core temperature changes. Anesth Analg. 1995 Mar;80(3):562-7. doi: 10.1097/00000539-199503000-00023.
PubMed 7864426Morris RH, Wilkey BR. The effects of ambient temperature on patient temperature during surgery not involving body cavities. Anesthesiology. 1970 Feb;32(2):102-7. doi: 10.1097/00000542-197002000-00003. No abstract available.
PubMed 5414287National Collaborating Centre for Nursing and Supportive Care (UK). The Management of Inadvertent Perioperative Hypothermia in Adults [Internet]. London: Royal College of Nursing (UK); 2008 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK53797/
PubMed 21678626Shaw CA, Steelman VM, DeBerg J, Schweizer ML. Effectiveness of active and passive warming for the prevention of inadvertent hypothermia in patients receiving neuraxial anesthesia: A systematic review and meta-analysis of randomized controlled trials. J Clin Anesth. 2017 May;38:93-104. doi: 10.1016/j.jclinane.2017.01.005. Epub 2017 Jan 31.
PubMed 28372696Tramontini CC, Graziano KU. Hypothermia control in elderly surgical patients in the intraoperative period: evaluation of two nursing interventions. Rev Lat Am Enfermagem. 2007 Jul-Aug;15(4):626-31. doi: 10.1590/s0104-11692007000400016.
PubMed 17923980Welch TC. AANA journal course. Update for nurse anesthetists. A common sense approach to hypothermia. AANA J. 2002 Jun;70(3):227-31.
PubMed 12078471Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
PubMed 21126665
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort
- ClinicalTrials.gov ID
- NCT05131568
- Acronym / sponsor ID
- SIT-3c / SIT-3c
- Conditions
- Perioperative Hypothermia
- Keywords
- perioperative hypothermia, thermal insulation, perioperative comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 23 Nov 2021 (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.
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.
Detailed description
Protecting patients from the cold in the operating room is a complex problem that has encouraged the search for better and more effective thermal protection systems. Some disadvantages have been observed in the daily use of the recommended thermal protection system (forced warm air).
This study intends to design and evaluate the effectiveness of a three-layer thermal insulation system, comparing its effect with the forced warm air system on temperature variation, shivering incidence and comfort perception, in patients undergoing total knee arthroplasty under neuro-axial anesthesia, during the intra-operative phase.
Participants are randomly assigned to the experimental group (EG) or control group (CG). The experimental group receives as a skin protection the three-layer thermal insulation system (SIT-3c) and the control group receives the usual recommended system (forced warm air).
Both systems are placed at the entrance to the operating room and held on patients during the entire intra-operative phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal insulation system | Experimental | Device: Layered thermal insulation systemexperimental: layered thermal insulation system The system was applied in the upper body to the entrance of the operating room and remained until the exit of the same room. The test included the evaluation of temperature, tremors and the visual perception of thermal comfort in 6 moments (T1 - reference temperature - at the entrance of the anesthetic induction room, T2 - at the entrance to the operating room, T3, T4 and T5 - fifteen , thirty and forty-five minutes after the start of surgery, and T6 - leaving the operating room) |
| Forced air active warming | No intervention | –Control: the same procedures as in the experiment group, were carried out in the control group, except for the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- With hypothermia or hyperthermia, scheduled for general anesthesia, pregnancy
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 |
|---|---|---|
| Layered thermal insulation systemNo other intervention | Device | Thermal insulation system |
Primary outcome
Changes in tympanic temperature (T1)
Time frame: Baseline (entrance in the operating room)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T2)
Time frame: immediately after anesthesia
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T3)
Time frame: 15 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T4)
Time frame: 30 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T5)
Time frame: 45 minutes after beginning surgery
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in tympanic temperature (T6)
Time frame: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the TTS-400 thermometer, Smiths Medical was used
Changes in shivering (T1)
Time frame: Baseline (entrance in the operating room)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T2)
Time frame: immediately after anesthesia
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T3)
Time frame: 15 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T4)
Time frame: 30 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T5)
Time frame: 45 minutes after beginning surgery
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in shivering (T6)
Time frame: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the Leslie and Sessler Scale, which measures tremors at three levels (0 - no tremors; 1 - slight tremors; 2 - vigorous tremors).
Changes in visual perception of Thermal comfort (T1)
Time frame: Baseline (entrance in the operating room)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T2)
Time frame: immediately after anesthesia
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T3)
Time frame: 15 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T4)
Time frame: 30 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T5)
Time frame: 45 minutes after beginning surgery
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
Changes in visual perception of Thermal comfort (T6)
Time frame: Up to 10 min after the end of surgery (living the operating room)
Method of assessment - the Visual Comfort Scale, which measures the perception of thermal comfort in two components: numerical (1 to 10) and visual (5 faces). The numerical component varies between 0 (very cold) and 10 (very hot), the value of the thermal neutrality, which means thermal comfort, identified in point 5; and the visual component where five expressive faces are presented. The first one, located between the numbers 0-2, shows strong cold discomfort, the second, located between 2-4, expressed cold discomfort, the third, located in the area of the number 5, expresses a sensation of thermal comfort, the fourth, located between the numbers 6-8, reveals heat discomfort and the fifth, located between 8-10, shows strong heat discomfort.
3 secondary outcomes
General intraoperative comfort
Time frame: 30 minutes after beginning surgery
Thermal intraoperative comfort
Time frame: 30 minutes after beginning surgery
Ergonomic comfort
Time frame: 30 minutes after beginning surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 17533677AORN Recommended Practices Committee. Recommended practices for the prevention of unplanned perioperative hypothermia. AORN J. 2007 May;85(5):972-4, 976-84, 986-8. doi: 10.1016/j.aorn.2007.04.015. No abstract available.
- Background: PubMed 16700681Fallis WM, Hamelin K, Symonds J, Wang X. Maternal and newborn outcomes related to maternal warming during cesarean delivery. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):324-31. doi: 10.1111/j.1552-6909.2006.00052.x.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 10781278Frank SM, El-Rahmany HK, Cattaneo CG, Barnes RA. Predictors of hypothermia during spinal anesthesia. Anesthesiology. 2000 May;92(5):1330-4. doi: 10.1097/00000542-200005000-00022.
- Background: PubMed 24267622Koeter M, Leijtens B, Koeter S. Effect of thermal reflective blanket placement on hypothermia in primary unilateral total hip or knee arthroplasty. J Perianesth Nurs. 2013 Dec;28(6):347-52. doi: 10.1016/j.jopan.2012.08.007.
- Background: PubMed 7864426Kurz A, Sessler DI, Narzt E, Lenhardt R, Lackner F. Morphometric influences on intraoperative core temperature changes. Anesth Analg. 1995 Mar;80(3):562-7. doi: 10.1097/00000539-199503000-00023.
- Background: PubMed 5414287Morris RH, Wilkey BR. The effects of ambient temperature on patient temperature during surgery not involving body cavities. Anesthesiology. 1970 Feb;32(2):102-7. doi: 10.1097/00000542-197002000-00003. No abstract available.
- Background: PubMed 21678626National Collaborating Centre for Nursing and Supportive Care (UK). The Management of Inadvertent Perioperative Hypothermia in Adults [Internet]. London: Royal College of Nursing (UK); 2008 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK53797/
- Background: PubMed 28372696Shaw CA, Steelman VM, DeBerg J, Schweizer ML. Effectiveness of active and passive warming for the prevention of inadvertent hypothermia in patients receiving neuraxial anesthesia: A systematic review and meta-analysis of randomized controlled trials. J Clin Anesth. 2017 May;38:93-104. doi: 10.1016/j.jclinane.2017.01.005. Epub 2017 Jan 31.
- Background: PubMed 17923980Tramontini CC, Graziano KU. Hypothermia control in elderly surgical patients in the intraoperative period: evaluation of two nursing interventions. Rev Lat Am Enfermagem. 2007 Jul-Aug;15(4):626-31. doi: 10.1590/s0104-11692007000400016.
- Background: PubMed 12078471Welch TC. AANA journal course. Update for nurse anesthetists. A common sense approach to hypothermia. AANA J. 2002 Jun;70(3):227-31.
- Background: PubMed 21126665Hooper VD, Chard R, Clifford T, Fetzer S, Fossum S, Godden B, Martinez EA, Noble KA, O'Brien D, Odom-Forren J, Peterson C, Ross J, Wilson L; ASPAN. ASPAN's evidence-based clinical practice guideline for the promotion of perioperative normothermia: second edition. J Perianesth Nurs. 2010 Dec;25(6):346-65. doi: 10.1016/j.jopan.2010.10.006. No abstract available.
- 1\. Biazzotto, C. B., Brudniewski, M., Schmidt, A. P., \& Júnior, J. O. (2006). Hipotermia no Período Peri-Operatório. Rev Bras Anestesiol, 56(1), pp. 89-106.Link provided by the sponsor.
- Ferreira, J. C., \& Patino, C. M. (2016). Randomização: mais do que o lançamento de uma moeda. J Bras Pneumol, 42(5), pp. 310-310.Link provided by the sponsor.
- Insler, S., \& Sessler, D. (2006). Perioperative Thermoregulation and Temperature Monitoring. Anesth Clinic, 24, pp. 823-837.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Perioperative Hypothermia
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Not yet recruiting
Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
Perioperative Hypothermia
Recruiting
Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Hypothermia Following Anesthesia, Intraoperative Complications
Not yet recruitingObservational study
Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor
Intraoperative Temperature Monitoring, Body Temperature
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. This study is not recruiting at the moment.
Isaura Carvalho, Dr. principal investigator
Hospital of Prelada - Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Layered thermal insulation system in people with Perioperative Hypothermia, run by Universidade do Porto at 1 site in Portugal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2023. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tympanic temperature (T1) (time frame: Baseline (entrance in the operating room)). The study lists 18 primary outcomes in all. 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 NCT05131568, which also lists 12 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 31 Mar 2023.