Clinical trial NCT03617809: Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery
Official title: Prevention of Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia; Anesthesia
Anesthesia; Adverse Effect
Peroperative Complication
Postoperative Complications
Surgical Site Infection
Temperature Change, Body
Keywords: Prewarming
Perioperative hypothermia
Esophageal thermometer
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: University of Las Palmas de Gran Canaria
First posted: 2018-08-06
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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, long time periods of prewarming would not be efficient. Thus, the ideal warming time prior to the induction of anesthesia has long been investigated.

Due to the searching of optimal prewarming time, the conductance of this study is justified.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparoscopic urological surgery under general anesthesia.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Temperature
timeFrame: Through perioperative period, an average of 7 hours
measure: Temperature
timeFrame: 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:
measure: Surgical site infection
timeFrame: Through patient's stay in hospital, an average of 15 days
measure: Postoperative shivering (using a dichotomous scale: yes or no)
timeFrame: Immediate postoperative period, an average of 1 hour.
measure: Risk factors of perioperative hypothermia
timeFrame: Throughout the perioperative period, an average of 7 hours.
measure: Perioperative bleeding
timeFrame: Throughout the perioperative period, an average of 7 hours.
measure: Postoperative pain, using the visual analogue scale, from 0 to 10
timeFrame: Immediate postoperative period, an average of 1 hour.
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Doctor Negrin University Hospital
name: Ángel Becerra, MD
role: PRINCIPAL_INVESTIGATOR
References: