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

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.

Study Overview

• Status: Unknown
• Conditions: Patients Scheduled for Brain Surgery
• Intervention / Treatment: Device: conventional circuit; Device: conventional humidification circuit; Device: new humidifaction heat circuit

• Study Type: Interventional
• Enrollment (Anticipated): 117
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Seon Choi, MD; Phone Number: +82-2-2228-2428; Email: yschoi@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    • Contact: Yong Seon Choi, MD, Ph.D; Phone Number: +82-2-2227-4966; Email: yschoi@yush.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group C; general circuit group	Device: conventional circuit; The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted. The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.; Other Names: group C for control group (n=39)
Active Comparator: group H; warm circuit group	Device: conventional humidification circuit; The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted. The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.; Other Names: group H for conventional humidification circuit (n = 39)
Experimental: group SH; new warm circuit group	Device: new humidifaction heat circuit; The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted. The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups.; Other Names: group SH for new humidifaction heat circuit (n=39)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
core temperature	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
upper airway humidity	every 30 minute after induction of anesthesia until the end of anesthesia

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 1-2017-0087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No