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

• ClinicalTrials.gov Identifier: NCT03491332
• Recruitment Status: Recruiting
• First Posted: April 9, 2018
• Last Update Posted: March 18, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

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.

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 Design

• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. core temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
2. upper airway temperature [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
3. upper airway humidity [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]

Secondary Outcome Measures :

1. 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)
2. dead space [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
   % for Deadspace(Vd/Vt)
3. intrapulmonary shunt [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
   Qs/Qt,
4. respiratory variables [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
   mmHg for respiratory variables(PaO2, PaCO2, PvO2, PvCO2)
5. compliance [ Time Frame: every 30 minute after induction of anesthesia until the end of anesthesia ]
   L/cmH2O for compliance(△V/△P)

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Yong Seon Choi, MD; +82-2-2228-2428; yschoi@yuhs.ac

Locations

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

Sponsors and Collaborators

Yonsei University

More Information

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03491332
• Other Study ID Numbers: 1-2017-0087
• First Posted: April 9, 2018
• 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

Additional relevant MeSH terms:

Inflammation; Pathologic Processes