Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

NCT ID: NCT03630887

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2018-10-31

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.

Detailed Description

Maintaining patient's temperature above 36 grades Celsius throughout the perioperative period is challenging. Thus, it is essential to monitor temperature in order to be able to take measures to avoid the appearance of hypothermia. Once the temperature has decreased, its treatment is difficult since the application of heat to the body surface takes a long time to reach the core thermal compartment. Intraoperative warming alone cannot avoid postoperative hypothermia. The application of forced-air warming system during the preoperative period has been shown to be the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, it would not be efficient to provide a long-time prewarming in short-term surgical procedures. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection, the conductance of this clinical trial is justified.

Conditions

Hypothermia; Anesthesia; Perioperative/Postoperative Complications; Complication of Anesthesia; Temperature Change, Body; Anaesthesia Complication; Transurethral Resection Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prewarming during 15 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

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

Prewarming during 30 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

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

Prewarming during 45 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

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

Interventions

WarmTouch Model 5900, Covidien Ltd, Mansfield, USA

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: collaborator

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ángel Becerra, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. Negrin University Hospital

Locations

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 34675311 (View on PubMed)

Other Identifiers

RTU-2018-153-1

Identifier Type: -

Identifier Source: org_study_id