Effect of Prewarming on Microcirculatory Response

Coronary Artery Bypass Graft Triple Vessel Clinical Trial

Official title:

Effect of Prewarming on Microcirculatory Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186210
• Other study ID #: Prewarming_OPCAB
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.

Description:

Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• off-pump coronary artery bypass surgery

Exclusion Criteria:

• refuse to enroll

• cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula

• preoperative left ventricular ejection fraction < 35%

• preoperative continuous infusion of vasopressor or inotropes

• pregnancy

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Triple Vessel

Intervention

Device:
• prewarming
recovery slope StO2

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery Slope	We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.	3 hours after induction of anesthesia
Secondary	Tissue Oxygen Saturation		During the surgery, an average of 4 hours