Clinical trial NCT05131568: Thermal Insulation System in Inadvertent Hypothermia
Official title: Efficacy of a Thermal Insulation System in Inadvertent Hypothermia and Perioperative Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Hypothermia
Keywords: perioperative hypothermia
thermal insulation
perioperative comfort
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in tympanic temperature (T1)
timeFrame: Baseline (entrance in the operating room)
measure: Changes in tympanic temperature (T2)
timeFrame: immediately after anesthesia
measure: Changes in tympanic temperature (T3)
timeFrame: 15 minutes after beginning surgery
measure: Changes in tympanic temperature (T4)
timeFrame: 30 minutes after beginning surgery
measure: Changes in tympanic temperature (T5)
timeFrame: 45 minutes after beginning surgery
measure: Changes in tympanic temperature (T6)
timeFrame: Up to 10 min after the end of surgery (living the operating room)
measure: Changes in shivering (T1)
timeFrame: Baseline (entrance in the operating room)
measure: Changes in shivering (T2)
timeFrame: immediately after anesthesia
measure: Changes in shivering (T3)
timeFrame: 15 minutes after beginning surgery
measure: Changes in shivering (T4)
timeFrame: 30 minutes after beginning surgery
measure: Changes in shivering (T5)
timeFrame: 45 minutes after beginning surgery
measure: Changes in shivering (T6)
timeFrame: Up to 10 min after the end of surgery (living the operating room)
measure: Changes in visual perception of Thermal comfort (T1)
timeFrame: Baseline (entrance in the operating room)
measure: Changes in visual perception of Thermal comfort (T2)
timeFrame: immediately after anesthesia
measure: Changes in visual perception of Thermal comfort (T3)
timeFrame: 15 minutes after beginning surgery
measure: Changes in visual perception of Thermal comfort (T4)
timeFrame: 30 minutes after beginning surgery
measure: Changes in visual perception of Thermal comfort (T5)
timeFrame: 45 minutes after beginning surgery
measure: Changes in visual perception of Thermal comfort (T6)
timeFrame: Up to 10 min after the end of surgery (living the operating room)
Secondary outcomes:
measure: General intraoperative comfort
timeFrame: 30 minutes after beginning surgery
measure: Thermal intraoperative comfort
timeFrame: 30 minutes after beginning surgery
measure: Ergonomic comfort
timeFrame: 30 minutes after beginning surgery
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: University of Porto - Biomedical Sciences Institut
Study officials:
affiliation: Hospital of Prelada - Porto
name: Isaura Carvalho, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fallis 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.
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citation: Kurz 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.
citation: Morris 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.
citation: National 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/
citation: Shaw 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.
citation: Tramontini 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.
citation: Welch TC. AANA journal course. Update for nurse anesthetists. A common sense approach to hypothermia. AANA J. 2002 Jun;70(3):227-31.
citation: Hooper 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.