Perioperative Hypothermia in Patients Submitted to Transurethral Resection

NCT03527329 | Completed

• 1 other identifier: NAC120300
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as myocardial ischemia or perioperative bleeding. When the negative effects of anesthesia on temperature are aggravated by other factors, such as glycine infusion in transurethral resection, temperature can decrease even more. Once the temperature has decreased, its treatment is difficult. Preoperative warming prevents hypothermia, lowering the temperature gradient between core and peripheral compartments and reducing thermal redistribution. The most recent clinical practice guidelines advocate for active prewarming before induction of general anaesthesia since it is very effective in preventing perioperative hypothermia. However, the ideal warming time prior to the induction of anesthesia has long been investigated. This study aims to evaluate if different time periods of preoperative forced-air warming reduces the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will depend on the time the patient has to wait before entering in the operating theatre. Measurement of temperature will be performed using a tympanic thermometer. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.

Conditions

Hypothermia; Anesthesia; Peroperative Complication

Keywords

Prewarming; Tympanic temperature

Outcome Measures

Primary Outcomes (1)

• Temperature

  Asses the effect of prewarming in maintaining body temperature of patients undergoing elective transurethral resection.

  Through patient's stay in hospital, an average of 24 hours

Study Arms (2)

Prewarming

Active Prewarming will be performed using a forced-air blanket (WarmTouch lower body blanket, Covidien Ltd, Mansfield, USA) over the whole body and connected to a forced-air warmer (WarmTouch Model 5900, Covidien Ltd, Mansfield, USA). Patients will be warmed using a surgical blanket during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

Control

Non-active prewarming. Patients will be warmed using a surgical blanket during the intraoperative period. Tympanic thermometer (Genius 2 Tympanic Thermometer and Base, Covidien Ltd, Mansfield, USA) will be used to measure the temperature throughout the perioperative period.

Interventions

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA DEVICE

Forced-air warming will be applied following routine clinical practice. The pre-warming time will depend on the time the patient has to wait before entering in the operating room. Prewarming time will be recorded for each patient.

Prewarming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to undergo elective transurethral resection between March 2014 and April 2018. Three-hundred patients are included in this study and prewarming will be applied following routine clinical practice. The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.

You may qualify if:

• Patients undergoing elective Transurethral resection under general or spinal anesthesia.

You may not qualify if:

• Active infection
• Intake of antipyretics within 24 hours before surgery
• Neuropathy
• Thyroid disorders
• Peripheral vascular disease
• Skin lesions
• History of hypersensitivity to skin contact devices.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead
• University of Las Palmas de Gran Canaria: collaborator

Related Publications (5)

• Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.

  PMID: 26775126 BACKGROUND

• NICE. Inadvertent Perioperative Hypothermia: The Management of Inadvertent Perioperative Hypothermia in Adults. NICE Clinical Guideline No. 65, 2008.

  BACKGROUND

• 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.

  PMID: 21126665 BACKGROUND

• Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.

  PMID: 25837741 BACKGROUND

• Forbes SS, Eskicioglu C, Nathens AB, Fenech DS, Laflamme C, McLean RF, McLeod RS; Best Practice in General Surgery Committee, University of Toronto. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009 Oct;209(4):492-503.e1. doi: 10.1016/j.jamcollsurg.2009.07.002. Epub 2009 Aug 20. No abstract available.

  PMID: 19801323 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Intraoperative Complications

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Aurelio Rodríguez-Pérez, MD PhD

  Dr. Negrin University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 17, 2018
• Study Start: March 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05