Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

NCT03617809 | Completed

• 1 other identifier: 2018-089-1
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermia is a frequent perioperative complication. Its appearance can have deleterious effects such as perioperative bleeding or surgical site infection. 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 laparoscopic urological surgery under general anesthesia. This is an observational prospective study comparing routine practice of pre-warming in consecutive surgical patients scheduled to laparoscopic prostatectomy or nephrectomy between August and December 2018. In this study 64 - 96 patients will be included 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 an esophagic 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; Anesthesia; Adverse Effect; Peroperative Complication; Postoperative Complications; Surgical Site Infection; Temperature Change, Body

Keywords

Prewarming; Perioperative hypothermia; Esophageal thermometer

Outcome Measures

Primary Outcomes (2)

• Temperature

  Asses the effect of prewarming in maintaining body temperature of patients undergoing elective laparoscopic urological surgery.

  Through perioperative period, an average of 7 hours

• Temperature

  Differences in body core temperature throughout the perioperative period among different groups

  From the arrival to the pre-anesthesia room to one hour after the arrival to the postanesthetic care unit an average of 7 hours.

Secondary Outcomes (5)

• Surgical site infection

  Through patient's stay in hospital, an average of 15 days

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

  Immediate postoperative period, an average of 1 hour.

• Risk factors of perioperative hypothermia

  Throughout the perioperative period, an average of 7 hours.

• Perioperative bleeding

  Throughout the perioperative period, an average of 7 hours.

• Postoperative pain, using the visual analogue scale, from 0 to 10

  Immediate postoperative period, an average of 1 hour.

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. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period.

Procedure: Preoperative warming

Control

Non-active prewarming. Patients will be warmed using a surgical blanket during the intraoperative period. Esophageal thermometer will be used to measure the temperature throughout the intraoperative period.

Interventions

Preoperative warming PROCEDURE

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.

Prewarming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 prewarming in consecutive surgical patients scheduled to undergo elective laparoscopic urological surgery between August and December 2018. Ninety-nine patients will be 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 laparoscopic urological surgery under general 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

• Ángel Becerra: lead
• University of Las Palmas de Gran Canaria: collaborator

Study Sites (1)

Ángel Becerra

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

Location

MeSH Terms

Conditions

Hypothermia; Intraoperative Complications; Postoperative Complications; Surgical Wound Infection; Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Wound Infection; Infections

Study Officials

• Ángel Becerra, MD

  Doctor Negrin University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: August 6, 2018
• Primary Completion: October 24, 2019
• Study Completion: October 24, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

ES (1)