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Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection

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ClinicalTrials.gov Identifier: NCT03630887
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
University of Las Palmas de Gran Canaria
Information provided by (Responsible Party):
Ángel Becerra, Dr. Negrin University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypothermia; Anesthesia Perioperative/Postoperative Complications Complication of Anesthesia Temperature Change, Body Anaesthesia Complication Transurethral Resection Syndrome Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes.
Masking: Double (Care Provider, Investigator)
Masking Description: 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)
Primary Purpose: Prevention
Official Title: Prevention of Perioperative Hypothermia in Patients Submitted to Transurethral Resection
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Forced-air warming will be applied in the preanesthetic room during different time periods.

Experimental: 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.
Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Forced-air warming will be applied in the preanesthetic room during different time periods.

Experimental: 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.
Device: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Forced-air warming will be applied in the preanesthetic room during different time periods.




Primary Outcome Measures :
  1. Body Temperature (using tympanic thermometer) [ Time Frame: Through patient's stay in hospital, an average of 24 hours. ]
    Asses the effect of prewarming in maintaining body temperature of patients undergoing elective transurethral resection.


Secondary Outcome Measures :
  1. Length of stay in Post-Anesthetic Care Unit (in minutes) [ Time Frame: Stay in Post-Anesthetic Care Unit, an average of 6 hours. ]
    Asses the effect of prewarming in reducing the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection.

  2. Postoperative shivering (using a dichotomous scale: yes or no) [ Time Frame: Immediate postoperative period, an average of 1 hour. ]
    Asses the effect of prewarming in reducing the postoperative shivering of patients undergoing elective transurethral resection.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630887


Contacts
Contact: Ángel Becerra, MD +34676229025 ext +34676229025 angbecbol@gmail.com
Contact: Aurelio Rodríguez-Pérez, MD PhD +34928450370 ext +34676229025 arodperp@gobiernodecanarias.org

Locations
Spain
Ángel Becerra Recruiting
Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
Contact: Ángel Becerra, MD    +34676229025      
Contact       angbecbol@gmail.com   
Sponsors and Collaborators
Dr. Negrin University Hospital
University of Las Palmas de Gran Canaria
Investigators
Principal Investigator: Ángel Becerra, MD Dr. Negrin University Hospital

Responsible Party: Ángel Becerra, Principal Investigator, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT03630887     History of Changes
Other Study ID Numbers: RTU-2018-153-1
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ángel Becerra, Dr. Negrin University Hospital:
Prewarming
Tympanic temperature
Transurethral Resection

Additional relevant MeSH terms:
Hypothermia
Postoperative Complications
Body Temperature Changes
Signs and Symptoms
Pathologic Processes