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Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study

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Yonsei University

Status

Unknown

Conditions

Patients Scheduled for Brain Surgery

Treatments

Device: conventional humidification circuit
Device: new humidifaction heat circuit
Device: conventional circuit

Study type

Interventional

Funder types

Other

Identifiers

NCT03491332
1-2017-0087

Details and patient eligibility

About

Mechanical respiration during general anesthesia causes cold and dry gases to reach the lower airway, reduce the function of the airway mucosa, and cause accumulation of secretions. Inhaled dry gas is one of the causes of hypothermia during general anesthesia. To overcome this, the warm-humidifying breathing circuit uses warm, moisture-preserving gas to promote mucus mobility of the airway mucosal ciliate cells and prevents cold gases from evaporating from the mucosal surfaces which results lowering body temperature. We aimed to investigate the effect of newly developed Sohum warm humidifying respiration circuit (SH501) on the prevention of core body temperature reduction during surgery and systemic inflammation reaction.

Enrollment

117 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. age ≥ 19
  2. scheduled for brain surgery

Exclusion criteria

  1. age < 19
  2. patients with severe obstructive lung disease and/or restrictive lung disease patients
  3. patients with infectious disease
  4. surgery with prone position or lateral position
  5. arrhythmia

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

117 participants in 3 patient groups, including a placebo group

group C
Placebo Comparator group
Description:
general circuit group
Treatment:
Device: conventional circuit
group H
Active Comparator group
Description:
warm circuit group
Treatment:
Device: conventional humidification circuit
group SH
Experimental group
Description:
new warm circuit group
Treatment:
Device: new humidifaction heat circuit

Trial contacts and locations

1

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Central trial contact

Yong Seon Choi, MD

Data sourced from clinicaltrials.gov

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