Perioperative Hypothermia in Patients Submitted to Laparoscopic Urological Surgery

NCT ID: NCT03617809

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2019-10-24

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.

Conditions

Hypothermia; Anesthesia; Anesthesia; Adverse Effect; Peroperative Complication; Postoperative Complications; Surgical Site Infection; Temperature Change, Body

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Preoperative warming

Intervention Type: 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.

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.

No interventions assigned to this group

Interventions

Preoperative warming

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.

Intervention Type: PROCEDURE

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.

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

Sponsors

University of Las Palmas de Gran Canaria

OTHER

Sponsor Role: collaborator

Ángel Becerra

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ángel Becerra, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor Negrin University Hospital

Locations

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Countries

Spain

Other Identifiers

2018-089-1

Identifier Type: -

Identifier Source: org_study_id