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

NCT ID: NCT03491332

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-01-31

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.

Conditions

Patients Scheduled for Brain Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group C

general circuit group

Group Type: PLACEBO_COMPARATOR

conventional circuit

Intervention Type: DEVICE

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.

group H

warm circuit group

Group Type: ACTIVE_COMPARATOR

conventional humidification circuit

Intervention Type: DEVICE

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.

group SH

new warm circuit group

Group Type: EXPERIMENTAL

new humidifaction heat circuit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

group C for control group (n=39); group H for conventional humidification circuit (n = 39); group SH for new humidifaction heat circuit (n=39)

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yong Seon Choi, MD

Role: CONTACT

yschoi@yuhs.ac

+82-2-2228-2428

Facility Contacts

Yong Seon Choi, MD, Ph.D

Role: primary

yschoi@yush.ac

+82-2-2227-4966

Other Identifiers

1-2017-0087

Identifier Type: -

Identifier Source: org_study_id