Peripheral Arterial DiseaseNCT06310928
The Effect of Thermal Blanket After Peripheral Artery Surgery
A study testing Thermal Blanket in people with Peripheral Arterial Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Thermal Blanket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to Mar 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Performing peripheral arterial surgery
- BMI<30
- No verbal communication barrier
Who cannot join
- Presence of orthopedic disability in the extremity undergoing the surgical procedure,
- Having a neurological disease
- Lack of pain control
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sağlık Bilimleri University
Istanbul, Uskudar, 34674
BIRGUL AYDOGAN, RN, +905336337651, 201001077@ogrenci.sbu.edu.tr
SONAY GÖKTAŞ, PROF.DR., +905324567776, sonay.goktas@sbu.edu.tr
About this study
Official title: The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation, Pain and Mobilization
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Thermal Blanket
- Keywords
- Thermal Blanket, Effect, Pain, Mobilization, Circulation
- Medical subject headings
- Peripheral Arterial Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal BlanketOther
Thermal blankets, a passive heating blanket, have a silver surface to prevent heat loss through radiation. Thermal insulation is achieved thanks to the fact that they are covered with a reflective surface to reflect light radiation, i.e. thermal radiation. It is a cost-effective, easy-to-clean, flexible material that takes the desired shape. Thermal blankets generate heat by providing thermal insulation with infrared radiation and can provide thermal vasodilation or thermotherapy. In 2013, Lima et al. used infrared thermal blankets to provide thermal vasodilation and as a result, it was found to reduce vascular resistance. Therefore, FORCLAZ brand blanket, also known as emergency blanket, used in natural disaster management, peripheral vascular resistance studies and hypothermia prevention studies was used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Thermal Blanket Intervention Group | Experimental | After the informed consent form is signed by the patients, general body warming of the patient will be provided with the hot air blowing system after surgery. In the 30th minute of the active heating method, a thermal blanket will be applied to the treated area (extremity) of the patient. The first 24 hours after the application; Pain will be evaluated every hour for the first 8 hours, every 2 hours for the second 8 hours, every 4 hours for the last 8 hours with the VAS Pain Scale and circulation with the Neurovascular Diagnosis Form. Mobilization of the patient for the first time in the 8th hour and for the second time in the 24th hour will be evaluated with the Patient and Observer Mobility Scale. Pain and neurovascular evaluation will be performed every 12 hours on the second postoperative day. Mobility will be assessed for the third time on the second postoperative day. Receives: Other: Thermal Blanket |
| Control Group | No intervention | After the informed consent form was signed by the patients who agreed to participate in the study before the application and who met the inclusion criteria, respectively;The vital signs of patients admitted to the intensive care unit after surgery will be stabilized.The patient's general warming of the body will be ensured with the hot air blowing system (Forced-air), which is an active heating method.Afterwards, the treated extremity will be wrapped with cotton alban, which is a routine application.Tests will be performed to the participants in the control group at the same time as in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation
After peripheral arterial surgery, there is a difference between the circulatory function of patients with and without thermal blankets. Circulation will be assessed 16 times with the neurovascular diagnostic form (NVT) scale in patients with thermal blankets postoperatively. Among the sub-parameters of the neurovascular diagnosis scale; skin color of the extremity (pink / red / pale / cyanotic), capillary filling time (less than 3-5 seconds), skin temperature (warm / hot / cold), pulse (strong / weak), edema (+ edema / + + + edema / absent), pain (present / absent), sensation (normal / numb / no sensation) and movement (normal / limited / no movement) will be examined. Normal findings include pink skin color and warm skin temperature, movement of extremities and fingers, tactile perception without numbness or tingling, strong and easily palpable pulses, capillary refill returning within 3-5 seconds, and absence of pain and edema.
Measured: 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 (1)
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain
There is a difference between the pain levels of patients with and without a thermal blanket applied to the area after peripheral arterial surgery. Pain was evaluated 16 times with the VAS (Visual Analog Scale) scale in patients who were applied a thermal blanket to the area after peripheral arterial surgery. Patients were asked to mark on a 10 cm long ruler to evaluate their pain. The distance between the point they marked and no pain is recorded in centimeters. Accordingly, "0" indicates no pain, while the average VAS value of 1-4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 May 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SONAY GÖKTAŞ, Saglik Bilimleri Universitesi
- Investigators
- BIRGUL AYDOGAN, RN, Principal investigator, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310928
- Sponsor's protocol ID
- SBU-201001077-2022
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34593660Simegn 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.
PubMed 34840773Torossian 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.
PubMed 27687449Lima 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.
PubMed 25070123Aboyans 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.
PubMed 28851596Gerhard-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.
PubMed 27840333Olin 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.
PubMed 26988957Seretny 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.
PubMed 27566812
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation, Pain and Mobilization
- ClinicalTrials.gov ID
- NCT06310928
- Acronym / sponsor ID
- SBU-201001077-2022
- Conditions
- Peripheral Arterial Disease
- Keywords
- Thermal Blanket, Effect, Pain, Mobilization, Circulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 15 Mar 2024 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thermal Blanket Intervention Group | Experimental | Other: Thermal BlanketAfter the informed consent form is signed by the patients, general body warming of the patient will be provided with the hot air blowing system after surgery. In the 30th minute of the active heating method, a thermal blanket will be applied to the treated area (extremity) of the patient. The first 24 hours after the application; Pain will be evaluated every hour for the first 8 hours, every 2 hours for the second 8 hours, every 4 hours for the last 8 hours with the VAS Pain Scale and circulation with the Neurovascular Diagnosis Form. Mobilization of the patient for the first time in the 8th hour and for the second time in the 24th hour will be evaluated with the Patient and Observer Mobility Scale. Pain and neurovascular evaluation will be performed every 12 hours on the second postoperative day. Mobility will be assessed for the third time on the second postoperative day. |
| Control Group | No intervention | –After the informed consent form was signed by the patients who agreed to participate in the study before the application and who met the inclusion criteria, respectively;The vital signs of patients admitted to the intensive care unit after surgery will be stabilized.The patient's general warming of the body will be ensured with the hot air blowing system (Forced-air), which is an active heating method.Afterwards, the treated extremity will be wrapped with cotton alban, which is a routine application.Tests will be performed to the participants in the control group at the same time as in the experimental group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study,
- Performing peripheral arterial surgery
- BMI<30
- No verbal communication barrier
Key exclusion criteria (3 listed)
- Presence of orthopedic disability in the extremity undergoing the surgical procedure,
- Having a neurological disease
- Lack of pain control
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 |
|---|---|---|
| Thermal BlanketThermal blankets, a passive heating blanket, have a silver surface to prevent heat loss through radiation. Thermal insulation is achieved thanks to the fact that they are covered with a reflective surface to reflect light radiation, i.e. thermal radiation. It is a cost-effective, easy-to-clean, flexible material that takes the desired shape. Thermal blankets generate heat by providing thermal insulation with infrared radiation and can provide thermal vasodilation or thermotherapy. In 2013, Lima et al. used infrared thermal blankets to provide thermal vasodilation and as a result, it was found to reduce vascular resistance. Therefore, FORCLAZ brand blanket, also known as emergency blanket, used in natural disaster management, peripheral vascular resistance studies and hypothermia prevention studies was used in this study. | Other | Thermal Blanket Intervention Group |
Primary outcome
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation
Time frame: 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
After peripheral arterial surgery, there is a difference between the circulatory function of patients with and without thermal blankets. Circulation will be assessed 16 times with the neurovascular diagnostic form (NVT) scale in patients with thermal blankets postoperatively. Among the sub-parameters of the neurovascular diagnosis scale; skin color of the extremity (pink / red / pale / cyanotic), capillary filling time (less than 3-5 seconds), skin temperature (warm / hot / cold), pulse (strong / weak), edema (+ edema / + + + edema / absent), pain (present / absent), sensation (normal / numb / no sensation) and movement (normal / limited / no movement) will be examined. Normal findings include pink skin color and warm skin temperature, movement of extremities and fingers, tactile perception without numbness or tingling, strong and easily palpable pulses, capillary refill returning within 3-5 seconds, and absence of pain and edema.
1 secondary outcome
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Pain
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 34593660Kim 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.
- Background: PubMed 34840773Simegn 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.
- Background: PubMed 27687449Torossian 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.
- Background: PubMed 25070123Lima 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.
- Background: PubMed 28851596Aboyans 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.
- Background: PubMed 27840333Gerhard-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.
- Background: PubMed 26988957Olin 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.
- Background: PubMed 27566812Seretny 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.
- Turkish Society of Cardiovascular Surgery National Society of Vascular and Endovascular Surgery Phlebology Society.(2021). National Treatment Guide for Peripheral Artery and Vein Diseases.Link provided by the sponsor.
- ESC Diagnosis of Peripheral Arterial Diseases and Treatment GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
BIRGUL AYDOGAN, RN principal investigator
Saglik Bilimleri University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal Blanket in people with Peripheral Arterial Disease, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgül Aydoğan, RN (+905336337651, 201001077@ogrenci.sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation (time frame: 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). 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 NCT06310928, which also lists 8 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 15 Mar 2024.