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

Patients Scheduled for Brain Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03491332
• Other study ID #: 1-2017-0087
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 2020

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: Yong Seon Choi, MD
• Phone: +82-2-2228-2428
• Email: yschoi[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Patients Scheduled for Brain Surgery

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	core temperature		every 30 minute after induction of anesthesia until the end of anesthesia
Primary	upper airway temperature		every 30 minute after induction of anesthesia until the end of anesthesia
Primary	upper airway humidity		every 30 minute after induction of anesthesia until the end of anesthesia
Secondary	cytokine level	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
Secondary	dead space	% for Deadspace(Vd/Vt)	every 30 minute after induction of anesthesia until the end of anesthesia
Secondary	intrapulmonary shunt	Qs/Qt,	every 30 minute after induction of anesthesia until the end of anesthesia
Secondary	respiratory variables	mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)	every 30 minute after induction of anesthesia until the end of anesthesia
Secondary	compliance	L/cmH2O for compliance(?V/?P)	every 30 minute after induction of anesthesia until the end of anesthesia