Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

NCT03630887 | Completed

• 1 other identifier: RTU-2018-153-1
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermia is a frequent perioperative complication. 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. 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 the optimal time period of preoperative forced-air warming to reduce the incidence of hypothermia at the end of surgery in patients submitted to transurethral resection. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 144 patients are going to be included in this study (36 patients in each group). 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; Perioperative/Postoperative Complications; Complication of Anesthesia; Temperature Change, Body; Anaesthesia Complication; Transurethral Resection Syndrome

Keywords

Prewarming; Tympanic temperature; Transurethral Resection

Outcome Measures

Primary Outcomes (1)

• Differences in Body Temperature among different treatment groups (using tympanic and esophageal thermometers)

  To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection.

  Throughout surgery, an average of 60 minutes.

Secondary Outcomes (2)

• Length of stay in Post-Anesthetic Care Unit (in minutes)

  Stay in Post-Anesthetic Care Unit, an average of 6 hours.

• Postoperative shivering (using a dichotomous scale: yes or no)

  Immediate postoperative period, an average of 1 hour.

Study Arms (4)

Control

NO INTERVENTION

Non-active prewarming. Patients will be actively warmed 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.

Prewarming during 15 minutes

EXPERIMENTAL

Active Prewarming will be performed during 15 minutes, 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 actively warmed 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

Prewarming during 30 minutes

EXPERIMENTAL

Active Prewarming will be performed during 30 minutes, 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 actively warmed 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

Prewarming during 45 minutes

EXPERIMENTAL

Active Prewarming will be performed during 45 minutes, 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 actively warmed 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

Interventions

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA DEVICE

Forced-air warming will be applied in the preanesthetic room during different time periods.

Prewarming during 15 minutes; Prewarming during 30 minutes; Prewarming during 45 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective Transurethral resection under general or spinal anesthesia.
• Patients older tan 18 years old.
• American Society of Anesthesiologists physical status classification I - III.
• Absence of cognitive impairment.
• Written informed consent before enrollment.

You may not qualify if:

• American Society of Anesthesiologists physical status classification I - III.
• Pregnancy.
• 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

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

Related Publications (1)

• Becerra A, Valencia L, Saavedra P, Rodriguez-Perez A, Villar J. Effect of prewarming on body temperature in short-term bladder or prostatic transurethral resection under general anesthesia: A randomized, double-blind, controlled trial. Sci Rep. 2021 Oct 21;11(1):20762. doi: 10.1038/s41598-021-00350-2.

  PMID: 34675311 DERIVED

MeSH Terms

Conditions

Hypothermia; Postoperative Complications; Body Temperature Changes; Transurethral resection syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Ángel Becerra, MD

  Dr. Negrin University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be carried out by a collaborator investigator using a computer program (Excel 2016) when a new patient is included into the clinical trial. This collaborator investigator will call by phone the nurse in charge of receiving the patient in the preanesthetic room, telling this nurse how long prewarming has to be given to the patient: 0 minutes (no prewarming), 15 minutes, 30 minutes or 45 minutes, according to the group given by the computer program. This collaborator investigator will not provide clinical care to the patient. Thus, principal investigator will not be able to know how long prewarming will be given by the nurse to the patient (chosen by the computer program and organized by a collaborator investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. Sample size was authorized by IRB to be changed from 144 to 244 (61 patients per group) due to possible missing data.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 15, 2018
• Study Start: August 14, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

ES (1)