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

Not Applicable

• Conditions: Patients Scheduled for Brain Surgery
• Interventions: Device: conventional circuit; Device: new humidifaction heat circuit; Device: conventional humidification circuit

• Registration Number: NCT03491332
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-08
• Study Start: 2018-04-01
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

1. age ≥ 19
2. scheduled for brain surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	conventional circuit	general circuit group
group SH	new humidifaction heat circuit	new warm circuit group
group H	conventional humidification circuit	warm circuit group

Primary Outcome Measures

Name	Time	Method
core temperature	every 30 minute after induction of anesthesia until the end of anesthesia
upper airway humidity	every 30 minute after induction of anesthesia until the end of anesthesia
upper airway temperature	every 30 minute after induction of anesthesia until the end of anesthesia

Secondary Outcome Measures

Name	Time	Method
respiratory variables	every 30 minute after induction of anesthesia until the end of anesthesia	mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
intrapulmonary shunt	every 30 minute after induction of anesthesia until the end of anesthesia	Qs/Qt,
cytokine level	1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation	pg/ml for Cytokine level(TNF-a, IL-1, IL-6, IL-8, IL-10)
dead space	every 30 minute after induction of anesthesia until the end of anesthesia	% for Deadspace(Vd/Vt)
compliance	every 30 minute after induction of anesthesia until the end of anesthesia	L/cmH2O for compliance(△V/△P)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of