The Effect of Sock Developed With Wearable Technology for TUR Surgery Patients on Hypothermia and Venous Thromboembolism

Venous Thromboembolism Clinical Trial

Official title:

The Effect of Sock Developed wıth Wearable Technology for Patıents Undergoıng Transurethral Resectıon Surgery on the Development of Hypothermıa and Venous Thromboembolısm

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05887518
• Other study ID #: MU-BOZKUL-002
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Tarsus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to examine the effect of the sock to be developed with wearable technology for patients who will undergo TUR surgery on the development of hypothermia and VTE. The population of the study will consist of patients who will undergo TUR surgery between 01 October 2023 and 01 October 2024. patients will be included in the study. The study was planned as a prospective, two-arm (1:1), randomised controlled, double-blind clinical trial. The data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form". The hypothermia follow-up form includes "Shivering Level Diagnosis Form" and "Temperature Comfort Perception Scale" The descriptive variables of the patients included in the study will be expressed as mean ± standard deviation and median (maximum-minimum), percentage and frequency. In data analysis; dependent and independent t test will be used when parametric test preconditions are met. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analyses as further analysis. Post hoc power analysis will be performed after the sample size reaches 70.

Description:

The aim of this study is to examine the effect of the sock to be developed with wearable technology for patients who will undergo TUR surgery on the development of hypothermia and VTE. The population of the study will consist of patients who will undergo TUR surgery between 01October 2023 and 01 October 2024. patients will be included in the study. The study was planned as a prospective, two-arm (1:1), randomised controlled, double-blind clinical trial. The data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form". The hypothermia follow-up form includes "Shivering Level Diagnosis Form" and "Temperature Comfort Perception Scale" .Control group: Patients will be fitted with antiembolitic socks in the ward, and the control group will be fitted with the same looking socks developed before the patient is sent to the operating theatre and will be removed one day after the operation. In the study, the same-looking socks will be applied to all patients by the same coordinator. Verbal and written permission will be obtained from the patient/relative before the study is started. The data obtained from the patients will be recorded in the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form" before TUR. Study group: In addition to the routine treatment and care practices of the operating theatre, the patients included in the study group will wear antiembolytic socks and a heater sock to be developed with wearable technology. After the patients are fitted with antiembolitic socks in the ward, the socks to be developed with wearable technology will be fitted to the study group before the patient is sent to the operating theatre and will be removed one day after the operation. The socks to be used in the research (socks with the same appearance as the heating socks developed with wearable technology) will be developed by the researchers and a patent application will be made. The socks to be developed with wearable technology in the study will be applied to all patients by the same responsible researcher. Verbal and written consent will be obtained from the patient/relative before the start of the study. The data obtained from the patients will be recorded in the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form" before TUR. The "Hypothermia Monitoring Form" will be filled in when the patients' vital signs are taken into the operating room, after anaesthesia is given, at the 15th, 30th and 60th minutes of the surgical procedure, at the end of the surgical procedure, when they come to the recovery room, and when they are transferred from the recovery room to the ward.The descriptive variables of the patients included in the study will be expressed as mean ± standard deviation and median (maximum-minimum), percentage and frequency. In data analysis; dependent and independent t test will be used when parametric test preconditions are met. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analyses as further analysis. Post hoc power analysis will be performed after the sample size reaches 70.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Written and verbal permission to participate in the study was obtained,
• Conscious, orientated and co-operative,
• Who speaks and understands Turkish,
• Undergoing TUR surgery,
• Not hypothermic in the preoperative period,
• No peripheral vascular disease,
• Not allergic to sock material,
• Patients without devices that send electric current into the body (pacemaker, etc.)

Exclusion Criteria:

• Written and verbal permission to participate in the research could not be obtained,
• Unconscious, disorientated and uncooperative,
• Speaking Turkish and not understanding it,
• No TUR surgery,
• Hypothermic in the pre-operative period,
• With peripheral vascular disease,
• Allergic to sock material
• Patients with devices that send electric current into the body (pacemaker, etc.)

Related Conditions & MeSH terms

• Hypothermia
• Nurse
• Thromboembolism
• Transurethral Resection
• Venous Thromboembolism
• Wearable Devices

Intervention

Device:
• Socks Developed with Wearable Technology
This new material will have the ability to prevent hypothermia by rewarming the patient when the body temperature drops below 360C and will reduce the risk of DVT that may develop in patients due to hypothermia. Thus, a single material will be used for two important complications of the surgical process, such as hypothermia and DVT, which negatively affect patient outcomes. This situation suggests that this material developed with an innovative approach will be more cost effective.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tarsus University	Mersin University

References & Publications (23)

Association of Perioperative Registered Nurses (AORN). (2018). Guideline quick vew: venous thromboembolism. AORN, 107(2), 281-285

Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16. — View Citation

Bhindi B, Kool R, Kulkarni GS, Siemens DR, Aprikian AG, Breau RH, Brimo F, Fairey A, French C, Hanna N, Izawa JI, Lacombe L, McPherson V, Rendon RA, Shayegan B, So AI, Zlotta AR, Black PC, Kassouf W. Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text. Can Urol Assoc J. 2021 Aug;15(8):E424-E460. doi: 10.5489/cuaj.7367. No abstract available. — View Citation

Çam T. (2018). Kardiyovasküler cerrahi yogun bakim hastalarinda endotrakeal tüp tespitinde kullanilan yöntemlerin aspirasyon sirasindaki hemodinamik degiskenlere etkisi. (Yüksek Lisans Tezi). Mersin Üniversitesi Saglik Bilimleri Enstitüsü. Mersin.

Chopra, A., Singhal, A., (2021). Understanding the Wearable Technology. Proceedings of the International Conference on Innovative Computing & Communication (ICICC), http://dx.doi.org/10.2139/ssrn.3833316.

Duman A, & Yilmaz E (2016). Ortopedi ameliyatlarinda perioperatif hipotermi insidansi ve risk etmenleri. Çukurova Üniversitesi Tip Fakültesi Dergisi, 41(4), 687 - 694.

Guk K, Han G, Lim J, Jeong K, Kang T, Lim EK, Jung J. Evolution of Wearable Devices with Real-Time Disease Monitoring for Personalized Healthcare. Nanomaterials (Basel). 2019 May 29;9(6):813. doi: 10.3390/nano9060813. — View Citation

Gura V, Rivara MB, Bieber S, Munshi R, Smith NC, Linke L, Kundzins J, Beizai M, Ezon C, Kessler L, Himmelfarb J. A wearable artificial kidney for patients with end-stage renal disease. JCI Insight. 2016 Jun 2;1(8):e86397. doi: 10.1172/jci.insight.86397. — View Citation

Health Statistics Yearbook. (2020). Access address: https://dosyasb.saglik.gov.tr/Eklenti/43399 ,siy2020-tur-26052022pdf.pdf?0. Access date: 28.02.2023

Keramidas ME, Musizza B, Kounalakis SN, Mekjavic IB. Enhancement of the finger cold-induced vasodilation response with exercise training. Eur J Appl Physiol. 2010 May;109(1):133-40. doi: 10.1007/s00421-010-1374-1. Epub 2010 Feb 5. — View Citation

Kim LHC, Patel MI. Transurethral resection of bladder tumour (TURBT). Transl Androl Urol. 2020 Dec;9(6):3056-3072. doi: 10.21037/tau.2019.09.38. — View Citation

Lerner LB, McVary KT, Barry MJ, Bixler BR, Dahm P, Das AK, Gandhi MC, Kaplan SA, Kohler TS, Martin L, Parsons JK, Roehrborn CG, Stoffel JT, Welliver C, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I-Initial Work-up and Medical Management. J Urol. 2021 Oct;206(4):806-817. doi: 10.1097/JU.0000000000002183. Epub 2021 Aug 13. Erratum In: J Urol. 2021 Nov;206(5):1339. — View Citation

Leslie, S.W., Chargui, S., & Stormont, G. (2022). Transurethral Resection of The Prostate. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; January. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560884/.

Özsoy H. (2022). Total diz artroplastisi öncesi aktif isitmanin ameliyat sirasi vücut sicakligi ve konfora etkisi (Doktora Tezi). Ege Üniversitesi Saglik Bilimleri Enstitüsü. Izmir.

Pickham D, Berte N, Pihulic M, Valdez A, Mayer B, Desai M. Effect of a wearable patient sensor on care delivery for preventing pressure injuries in acutely ill adults: A pragmatic randomized clinical trial (LS-HAPI study). Int J Nurs Stud. 2018 Apr;80:12-19. doi: 10.1016/j.ijnurstu.2017.12.012. Epub 2017 Dec 30. — View Citation

Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28. — View Citation

Shei RJ, Holder IG, Oumsang AS, Paris BA, Paris HL. Wearable activity trackers-advanced technology or advanced marketing? Eur J Appl Physiol. 2022 Sep;122(9):1975-1990. doi: 10.1007/s00421-022-04951-1. Epub 2022 Apr 21. — View Citation

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation

Vural F, Celik B, Deveci Z, Yasak K. Investigation of inadvertent hypothermia incidence and risk factors. Turk J Surg. 2018 Dec 1;34(4):300-305. doi: 10.5152/turkjsurg.2018.3992. — View Citation

Wagner D, Byrne M, Kolcaba K. Effects of comfort warming on preoperative patients. AORN J. 2006 Sep;84(3):427-48. doi: 10.1016/s0001-2092(06)63920-3. — View Citation

Wang JW, Man LB. Transurethral resection of the prostate stricture management. Asian J Androl. 2020 Mar-Apr;22(2):140-144. doi: 10.4103/aja.aja_126_19. — View Citation

Yi J, Xiang Z, Deng X, Fan T, Fu R, Geng W, Guo R, He N, Li C, Li L, Li M, Li T, Tian M, Wang G, Wang L, Wang T, Wu A, Wu D, Xue X, Xu M, Yang X, Yang Z, Yuan J, Zhao Q, Zhou G, Zuo M, Pan S, Zhan L, Yao M, Huang Y. Incidence of Inadvertent Intraoperative Hypothermia and Its Risk Factors in Patients Undergoing General Anesthesia in Beijing: A Prospective Regional Survey. PLoS One. 2015 Sep 11;10(9):e0136136. doi: 10.1371/journal.pone.0136136. eCollection 2015. — View Citation

Yüksel, S. & Altun Ugras, G. (2016). Cerrahi hastasinda hipotermi gelisimini önlemede hemsirenin rolü. Mersin Üniversitesi Saglik Bilimleri Dergisi, 9 (2), 113-121. https://dergipark.org.tr/tr/pub/mersinsbd/issue/24537/259943.

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature	Hypothermia Monitoring Form: It is a form in which the body temperature, shivering level and temperature comfort perception of the patients and the time when the body temperature reached 360C in the postoperative period are recorded. Body temperature is recorded preoperatively (when the patient comes to the operating theatre preop preparation room, when the patient is taken to the operating room), intraoperatively (when anaesthesia is given, at the 30th and 60th minutes of the surgical intervention, at the end of the surgery). The level of shivering and temperature comfort perception will be measured preoperatively (when the patient comes to the operating theatre preop preparation room, when the patient is taken to the operating room) and postoperatively (when the patient comes to the recovery room, when the patient is transferred from the recovery room to the ward).	Perioperative period
Primary	Shivering level	Tremor Level Diagnosis Form: The form, which Badjaita et al. (2008) determined the criteria by observation, determines the level of tremor according to the tremor in the extremities between 0 (no tremor) and 3 (severe tremor in the trunk, lower and upper extremities) points.	Perioperative period
Primary	Comfort perception	Temperature Comfort Perception Scale: It is a visual analogue scale developed by Wagner (2006) to provide objective assessment of temperature comfort perception. In the scale, the level of temperature comfort perception is evaluated between 0 (extremely cold) - 10 (extremely hot) according to the patient's report.	Perioperative period
Secondary	Development of venous thromboembolism	Descriptive Characteristics Form: In the form prepared by the researchers in line with the literature, VTE development status will be questioned and recorded during hospitalisation.	Perioperative period
Secondary	Descriptive Characteristics	Descriptive Characteristics Form: The form created by the researcher in line with the literature consists of questions about the age, gender, educational status of the patients and the characteristics of the procedure.	Perioperative period