10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

NCT04991272 | Completed

• 1 other identifier: 2021-05-004
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming and warmed fluid during urologic surgery.

Conditions

Urologic Diseases

Keywords

hypothermia

Outcome Measures

Primary Outcomes (1)

• incidence of hypothermia at the end of the operation

  after completion of the operation, number of patients with hypothermia (\<36'C) using esophageal stethoscope will be recorded.

  approximately 1-2hours after induction (at the end of operation)

Secondary Outcomes (3)

• change in temperature before and end of operation

  on arrival at the OR upto 1-2hours after induction (at the end of the operation)

• incidence of shivering

  upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)

• thermal comfort

  upto 1hour after end of the operation (at discharge of postanesthesia care unit)

Study Arms (2)

warming group

ACTIVE COMPARATOR

Warming group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

Other: prewarming and warmed fluid infusion

no warming group

NO INTERVENTION

No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

Interventions

prewarming and warmed fluid infusion OTHER

prewarming with forced air warming system and warmed fluid infusion.

warming group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing urologic surgery(transurethral resection of bladder, prostate)

You may not qualify if:

• moderate to severe cardiopulmonary, renal impairment
• thyroid disease
• any infection sign
• abnormal temperature prior to induction of general anesthesia (\<36'C or \>37.5'C)
• refusal to participate in the study
• unable to understand the study

Sponsors & Collaborators

• Inje University: lead

Study Sites (1)

Sanggye Paik Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urologic Diseases; Hypothermia

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Jung Jun, MD. PhD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD. associate Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 5, 2021
• Study Start: July 1, 2021
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

KR (1)