Effect of Pre-warming on Perioperative Hypothermia During HoLEPunder Spinal Anesthesia

NCT03184506 | Completed

• 1 other identifier: 2017-05-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Inadvertent perioperative hypothermia is an unintentional drop in core body temperature below 36°C. Intraoperative hypothermia can lead to serious clinical complications such as, myocardial ischemia, coagulopathy, immunosuppression, and surgical wound infection. Hypothermia develops easily during surgeries that require irrigation fluid, such as laparoscopic surgery and transurethral resection of the prostate. Although isothermic irrigation fluid was suggested to prevent perioperative hypothermia, it can be difficult to warm a large volume of irrigation fluid. Re-distribution after induction of anesthesia is the most important cause of perioperative hypothermia. The extent of re-distribution is proportional to the gradient between the core and peripheral compartments. Pre-warming increases the heat content of the peripheral thermal compartment, reducing the gradient for redistribution. Recently, A recent-meta analysis suggested that as a single strategy, preoperative forced air warming had significant benefits than other warming methods. Also, it was reported that only 20 (or even 10) min of pre-warming mostly prevented patients from perioperative hypothermia under general anesthesia. However, few studies have examined whether short time pre-warming can reduce hypothermia due to a large amount of irrigation fluid during surgery under spinal anesthesia. The purpose of this study is to assess whether the application of preoperative forced air warming set to high temperature (\> 43°C) for brief period can prevent hypothermia or shivering during procedures requiring large volumes of cold irrigation.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• core temperature

  taken in the same ear using an infrared tympanic thermometer (ThermoScan IRT 1020; Braun, Germany), and the highest reading from three consecutive measurements was recorded.

  on admission to PACU

Secondary Outcomes (4)

• the incidence of perioperative hypothermia

  at baseline (preoperative care unit), on arrival at the OR, every 10 minutes after spinal anesthesia, and on admission to PACU 1 hour

• the incidence of shivering

  on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.

• Thermal comfort

  on arrival at the OR, at every 30 minutes after spinal anesthesia, on admission to PACU, and then every 30 minutes for 1 hour.

• core temperature

  at baseline (preoperative care unit), on arrival at the operation room, every 30 minutes after spinal anesthesia

Study Arms (2)

control group

SHAM COMPARATOR

Other: no warming

pre-warming group

ACTIVE COMPARATOR

Other: pre-warming

Interventions

pre-warming OTHER

On arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃

pre-warming group

no warming OTHER

patients were covered only with two layers of cotton blanket

control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with ASA physical status I-III, aged 50 - 80 years, undergoing HoLEP under spinal anesthesia

You may not qualify if:

• preoperative body temperature of more than 37.2°C preexisting severe cardiovascular, respiratory and endocrinal disease on anticoagulant therapy

Sponsors & Collaborators

• Hallym University Kangnam Sacred Heart Hospital: lead

Study Sites (1)

Kangnam Sared heart Hospital

Seoul, Yeongdeungpo-gu, 07441, South Korea

Location

Related Publications (1)

• Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.

  PMID: 30579334 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 12, 2017
• Study Start: June 12, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 4, 2019

Record last verified: 2017-06

Locations

KR (1)