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

March 14, 2019 updated by: Yonsei University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
117

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
core temperature
Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia
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
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
every 30 minute after induction of anesthesia until the end of anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
1, 30, 60, 90, 120, 150, 180, 210, 240 minute after induction and 1 second after the operation
dead space
Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia
% for Deadspace(Vd/Vt)
every 30 minute after induction of anesthesia until the end of anesthesia
intrapulmonary shunt
Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia
Qs/Qt,
every 30 minute after induction of anesthesia until the end of anesthesia
respiratory variables
Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia
mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
every 30 minute after induction of anesthesia until the end of anesthesia
compliance
Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia
L/cmH2O for compliance(△V/△P)
every 30 minute after induction of anesthesia until the end of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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