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

Primary Purpose

Patients Scheduled for Brain Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional circuit
conventional humidification circuit
new humidifaction heat circuit
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients Scheduled for Brain Surgery

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

group C

group H

group SH

Arm Description

general circuit group

warm circuit group

new warm circuit group

Outcomes

Primary Outcome Measures

core temperature
upper airway temperature
upper airway humidity

Secondary Outcome Measures

cytokine level
pg/ml for Cytokine level(TNF-a, IL-1, IL-6, IL-8, IL-10)
dead space
% for Deadspace(Vd/Vt)
intrapulmonary shunt
Qs/Qt,
respiratory variables
mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
compliance
L/cmH2O for compliance(△V/△P)

Full Information

First Posted
March 8, 2018
Last Updated
March 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03491332
Brief Title
Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Official Title
Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Scheduled for Brain Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group C
Arm Type
Placebo Comparator
Arm Description
general circuit group
Arm Title
group H
Arm Type
Active Comparator
Arm Description
warm circuit group
Arm Title
group SH
Arm Type
Experimental
Arm Description
new warm circuit group
Intervention Type
Device
Intervention Name(s)
conventional circuit
Other Intervention Name(s)
group C for control group (n=39)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
conventional humidification circuit
Other Intervention Name(s)
group H for conventional humidification circuit (n = 39)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
new humidifaction heat circuit
Other Intervention Name(s)
group SH for new humidifaction heat circuit (n=39)
Intervention Description
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.
Primary Outcome Measure Information:
Title
core temperature
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Title
upper airway temperature
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Title
upper airway humidity
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Secondary Outcome Measure Information:
Title
cytokine level
Description
pg/ml for Cytokine level(TNF-a, IL-1, IL-6, IL-8, IL-10)
Time Frame
1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation
Title
dead space
Description
% for Deadspace(Vd/Vt)
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Title
intrapulmonary shunt
Description
Qs/Qt,
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Title
respiratory variables
Description
mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia
Title
compliance
Description
L/cmH2O for compliance(△V/△P)
Time Frame
every 30 minute after induction of anesthesia until the end of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 19 scheduled for brain surgery Exclusion Criteria: age < 19 patients with severe obstructive lung disease and/or restrictive lung disease patients patients with infectious disease surgery with prone position or lateral position arrhythmia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Seon Choi, MD
Phone
+82-2-2228-2428
Email
yschoi@yuhs.ac
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Seon Choi, MD, Ph.D
Phone
+82-2-2227-4966
Email
yschoi@yush.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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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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