Effect of Prewarming on Microcirculatory Response

NCT ID: NCT02186210

Last Updated: 2019-03-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Bypass Graft Triple Vessel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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prewarming

prewarming during induction of anesthesia

Group Type EXPERIMENTAL

prewarming

Intervention Type DEVICE

recovery slope StO2

control

no prewarming during induction of anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prewarming

recovery slope StO2

Intervention Type DEVICE

Other Intervention Names

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prewarming by active air heater

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunseok Jeon, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho YJ, Lee SY, Kim TK, Hong DM, Jeon Y. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial. PLoS One. 2016 Jul 21;11(7):e0159772. doi: 10.1371/journal.pone.0159772. eCollection 2016.

Reference Type DERIVED
PMID: 27442052 (View on PubMed)

Other Identifiers

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Prewarming_OPCAB

Identifier Type: -

Identifier Source: org_study_id

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