Effect of Heated Breathing Circuit on Intraoperative Core Temperature and Systemic Inflammation After Brain Surgery: a Prospective Randomized Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03491332 |
Recruitment Status : Unknown
Verified March 2019 by Yonsei University.
Recruitment status was: Recruiting
First Posted : April 9, 2018
Last Update Posted : March 18, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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) |
- 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 ]
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Yong Seon Choi, MD | +82-2-2228-2428 | yschoi@yuhs.ac |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammation Pathologic Processes |