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Completed

NCT Number: NCT05131568

Thermal Insulation System in Inadvertent Hypothermia

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.

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Key information

Conditions

Perioperative Hypothermia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Porto - Biomedical Sciences Institut

Porto, 4050-313, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Layered thermal insulation system

Device

No other intervention

Primary outcomes

  1. Changes in tympanic temperature (T1)

    Time frame: Baseline (entrance in the operating room)

    Method of assessment - the TTS-400 thermometer, Smiths Medical was used

  2. Changes in tympanic temperature (T2)

    Time frame: immediately after anesthesia

    Method of assessment - the TTS-400 thermometer, Smiths Medical was used

  3. Changes in tympanic temperature (T3)

    Time frame: 15 minutes after beginning surgery

    Method of assessment - the TTS-400 thermometer, Smiths Medical was used

  4. Changes in tympanic temperature (T4)

    Time frame: 30 minutes after beginning surgery

    Method of assessment - the TTS-400 thermometer, Smiths Medical was used

  5. Changes in tympanic temperature (T5)

    Time frame: 45 minutes after beginning surgery

    Method of assessment - the TTS-400 thermometer, Smiths Medical was used

  6. 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

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Secondary outcomes

  1. General intraoperative comfort

    Time frame: 30 minutes after beginning surgery

    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.

  2. Thermal intraoperative comfort

    Time frame: 30 minutes after beginning surgery

    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.

  3. Ergonomic comfort

    Time frame: 30 minutes after beginning surgery

    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).

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort

Acronym: SIT-3c

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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