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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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ClinicalTrials.gov Identifier: NCT03491332
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients Scheduled for Brain Surgery Device: conventional circuit Device: conventional humidification circuit Device: new humidifaction heat circuit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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 Name: 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 Name: 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 Name: group SH for new humidifaction heat circuit (n=39)




Primary Outcome Measures :
  1. core temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
  2. upper airway temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
  3. upper airway humidity [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]

Secondary Outcome Measures :
  1. cytokine level [ Time Frame: 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)

  2. dead space [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    % for Deadspace(Vd/Vt)

  3. intrapulmonary shunt [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    Qs/Qt,

  4. respiratory variables [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)

  5. compliance [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    L/cmH2O for compliance(△V/△P)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491332


Contacts
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Contact: Yong Seon Choi, MD +82-2-2228-2428 yschoi@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Yong Seon Choi, MD, Ph.D    +82-2-2227-4966    yschoi@yush.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03491332    
Other Study ID Numbers: 1-2017-0087
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes