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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

Tracking Information
First Submitted Date  ICMJE March 8, 2018
First Posted Date  ICMJE April 9, 2018
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • core temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
  • upper airway temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
  • upper airway humidity [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
  • 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)
  • dead space [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    % for Deadspace(Vd/Vt)
  • intrapulmonary shunt [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    Qs/Qt,
  • respiratory variables [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
  • compliance [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
    L/cmH2O for compliance(△V/△P)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Official Title  ICMJE Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Patients Scheduled for Brain Surgery
Intervention  ICMJE
  • 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)
  • 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)
  • 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)
Study Arms  ICMJE
  • Placebo Comparator: group C
    general circuit group
    Intervention: Device: conventional circuit
  • Active Comparator: group H
    warm circuit group
    Intervention: Device: conventional humidification circuit
  • Experimental: group SH
    new warm circuit group
    Intervention: Device: new humidifaction heat circuit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
117
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yong Seon Choi, MD +82-2-2228-2428 yschoi@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03491332
Other Study ID Numbers  ICMJE 1-2017-0087
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP