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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03491332
Enrollment
117
Registered
2018-04-09
Start date
2018-04-01
Completion date
2020-01-31
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Scheduled for Brain Surgery

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.

Interventions

DEVICEconventional 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.

DEVICEconventional 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.

DEVICEnew 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
core temperatureevery 30 minute after induction of anesthesia until the end of anesthesia
upper airway temperatureevery 30 minute after induction of anesthesia until the end of anesthesia
upper airway humidityevery 30 minute after induction of anesthesia until the end of anesthesia

Secondary

MeasureTime frameDescription
respiratory variablesevery 30 minute after induction of anesthesia until the end of anesthesiammHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
cytokine level1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operationpg/ml for Cytokine level(TNF-a, IL-1, IL-6, IL-8, IL-10)
complianceevery 30 minute after induction of anesthesia until the end of anesthesiaL/cmH2O for compliance(△V/△P)
dead spaceevery 30 minute after induction of anesthesia until the end of anesthesia% for Deadspace(Vd/Vt)
intrapulmonary shuntevery 30 minute after induction of anesthesia until the end of anesthesiaQs/Qt,

Countries

South Korea

Contacts

Primary ContactYong Seon Choi, MD
yschoi@yuhs.ac+82-2-2228-2428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026