Clinical trial NCT06310928: The Effect of Thermal Blanket After Peripheral Artery Surgery
Official title: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation, Pain and Mobilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Thermal Blanket
Effect
Pain
Mobilization
Circulation
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single center randomized controlled clinical trial.The sample consisted of a total of 60 patients who would undergo interventional peripheral arterial surgery, met the study criteria and agreed to participate in this study. They will be divided into two groups as 30 experimental group and 30 control group by randomization method.
Primary purpose: OTHER

Brief summary: Peripheral arterial disease is one of the most common clinical conditions associated with cardiovascular morbidity and increased mortality, requiring exercise, antiaggregant and surgical revascularization therapy. As in peripheral arterial surgery, postoperative hypothermia is common in patients who have undergone surgical intervention and the duration of surgery is longer than 30 minutes due to the low temperature of the surgical environment or the suppression of the thermoregulation center by anesthetics and sedatives. With hypothermia, heat loss increases,peripheral vasoconstriction with activation of the sympathetic system, impaired perfusion at the surgical wound site, hypoxemia, coagulopathy, bleeding, postoperative pain, deterioration of thermal comfort, deterioration of patient comfort and prolonged hospital stay are reported. Many heating methods are used to achieve and maintain normal body temperature in the postoperative period, to prevent complications caused by hypothermia.Aluminum-coated thermal blankets are especially preferred. In this way, heat preservation, peripheral vasodilation and perfusion with the effect of temperature, reduction of muscle spasm with increased endorphin release, less pain, and increased comfort of the patient are provided. The thermal blanket is an easy-to-apply material that does not require any tools or electricity for its effectiveness and can come into direct contact with the patient's skin. It provides thermal insulation with its ability to reflect thermal radiation. Peripheral vasodilation and decreased peripheral vascular resistance have been observed with thermal therapy provided by thermal blankets. It is known that thermal blanket methods are used to warm patients in practice. However, the lack of a literature study on the regional effect of these applications on the patient has been noticed. For this purpose, in this study, the regional efficacy of thermal blankets on the patient was evaluated in order to reduce the narrowed arterial lumen and increased peripheral vascular resistance in peripheral arterial diseases and to prevent the vasoconstrictive effect of hypothermia on peripheral vessels. It was predicted that these blankets would maintain heat, increase tissue perfusion with peripheral vasodilation effect, facilitate circulation, reduce pain and facilitate mobilization.In line with this aim, the objectives are;

* To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery.
* To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery.
* To increase the patient's postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming.
* To contribute to the control of pain, neurovascular follow-up and reduction of damage and mobilization, which are the main nursing goals after surgery.
* To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets, thus providing an easy-to-apply, effective care in terms of nursing and increasing the quality of health care service.

Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patient's circulation, pain and mobilization.

Detailed description: The population of the study consisted of patients who were planned to undergo peripheral artery surgery under elective conditions in the Cardiovascular Surgery Clinic of Seyrantepe Hamidiye Etfal Training and Research Hospital between 2022 and 2024. The sample consisted of a total of 60 patients who would undergo interventional peripheral arterial surgery, met the study criteria and agreed to participate in this study. They will be divided into two groups as 30 experimental group and 30 control group by randomization method. Data will be collected by Patient Identification Form, Visual Analog Scale (VAS-Visual Analog Scale), Neurovascular Identification Form, Patient Mobility Scale and Observer Mobility Scale.

In the implementation phase of the study, intensive care and clinical nurses will be informed about this study after obtaining institutional permission. Before the study, the patients will be informed by the researcher and after the written consent of the patients who meet the criteria for participation in the study and accept the study is obtained with the "Informed Voluntary Consent Form", respectively;

* The patient will be diagnosed with the Patient Identification Form.
* After the admission of the patient in the postoperative intensive care unit and the vital signs will be stabilized.
* General body heating of both patient groups will be done with the hot air blowing system (Forced-air), which is an active heating method.
* In the intervention group, a digital temperature probe will be fixed to the treated area just before the application of the thermal blanket (30th minute of active heating) and the temperature will be monitored for 24 hours.
* In the 30th minute of the active heating method, a thermal blanket will be applied to the treated area (extremity) of the intervention group and this application will remain for 24 hours. In the control group, cotton dressings routinely used by the clinic will be used.
* The first 24 hours after application of the thermal blanket;

  * every hour for the first 8 hours,
  * every 2 hours for the second 8 hours,
  * In the last 8 hours, pain will be evaluated every 4 hours with VAS Pain Scale and circulation will be evaluated with Neurovascular Diagnostic Form in both groups.
* At the end of the 8th hour of the thermal blanket application, the patient's first mobilization will be evaluated in both groups with the Patient Mobility and Observer Mobility Scale.
* At the end of the 24th hour of the thermal blanket application, the second mobilization assessment of the patient will be made in both groups with the Patient and Observer Mobility Scale together with pain and circulation.
* 24 hours after surgery, both groups will be transferred to the Cardiovascular Surgery Clinic without any application.
* On the second postoperative day, pain, circulation with the neurovascular diagnostic form and mobilization with the Patient and Observer Mobility Scale will be evaluated every 12 hours in both groups.
* At the end of 48 hours, mobilization will be evaluated for the last time with the Patient Mobility and Observer Mobility Scale.

The data obtained in the study will be analyzed using SPSS(Statistical Package for Social Sciences) for Windows 22.0 program.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study,
* Performing peripheral arterial surgery
* BMI\<30
* No verbal communication barrier

Exclusion Criteria:

* Presence of orthopedic disability in the extremity undergoing the surgical procedure,
* Having a neurological disease
* Lack of pain control

Primary outcomes:
measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation
timeFrame: After applying a thermal blanket to the area, 1.2.3.4.5.6.7.8.10.12.14.16.20.24.36.48 hours
Secondary outcomes:
measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain
timeFrame: After applying a thermal blanket to the area, 1.2.3.4.5.6.7.8.10.12.14.16.20.24.36.48 hours
Other outcomes:
measure: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Mobilization
timeFrame: After applying a thermal blanket to the area, 8.24.48 hours
Locations:
city: Istanbul
country: Turkey
facility: Sağlık Bilimleri University
state: Uskudar
Study officials:
affiliation: Saglik Bilimleri University
name: BIRGUL AYDOGAN, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Kim EM, Oh PS, Lim ST, Sohn MH, Song EK, Park KU, Kim JY, Won KS, Jeong HJ. Usefulness of cyclic thermal therapy and red blood cell scintigraphy in patients with chemotherapy-induced peripheral neuropathy. Korean J Pain. 2021 Oct 1;34(4):427-436. doi: 10.3344/kjp.2021.34.4.427.
citation: Simegn GD, Bayable SD, Fetene MB. Prevention and management of perioperative hypothermia in adult elective surgical patients: A systematic review. Ann Med Surg (Lond). 2021 Nov 14;72:103059. doi: 10.1016/j.amsu.2021.103059. eCollection 2021 Dec.
citation: Torossian A, Van Gerven E, Geertsen K, Horn B, Van de Velde M, Raeder J. Active perioperative patient warming using a self-warming blanket (BARRIER EasyWarm) is superior to passive thermal insulation: a multinational, multicenter, randomized trial. J Clin Anesth. 2016 Nov;34:547-54. doi: 10.1016/j.jclinane.2016.06.030. Epub 2016 Jul 17.
citation: Lima MV, Ochiai ME, Vieira KN, Scipioni A, Cardoso JN, Munhoz RT, Morgado PC, Barretto AC. Thermal vasodilation using a portable infrared thermal blanket in decompensated heart failure. Int Heart J. 2014;55(5):433-9. doi: 10.1536/ihj.14-096. Epub 2014 Jul 28.
citation: Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tunon J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. No abstract available.
citation: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.
citation: Olin JW, White CJ, Armstrong EJ, Kadian-Dodov D, Hiatt WR. Peripheral Artery Disease: Evolving Role of Exercise, Medical Therapy, and Endovascular Options. J Am Coll Cardiol. 2016 Mar 22;67(11):1338-57. doi: 10.1016/j.jacc.2015.12.049.
citation: Seretny M, Colvin LA. Pain management in patients with vascular disease. Br J Anaesth. 2016 Sep;117 Suppl 2:ii95-ii106. doi: 10.1093/bja/aew212.