The Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions

Completed

• Conditions: Microcirculatory Alterations

• Registration Number: NCT02144298
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

The aim of this study is to observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood compared with cristalloid cardioplegia. Additionally the impact of changes in hemodynamic parameters, blood gas, laboratory findings and standart therapy for intra and early postoperative period was studied. Intubation time, ICU stay, hospital stay, ICU readmission, morbidity and mortality were recorded.

Detailed Description

The microcirculatory measurements were obtained in both groups in the sublingual mucosa using Cytocam imaging. The probe was handheld. Different precautions were taken and steps followed to obtain images of adequate quality and to ensure good reproducibility.

Images were made after induction of anesthesia (t0), before CBP 5 minutes after heparine (t1), 5 minutes after CBP beginning (t2), during CBP 10 minutes after crossclamp beginning (t3), after crossclamp ending when heart begins to beat (t4), after CBP 10 minutes after protamine (t5).

Additional images were made before (tc0) and after (tc1) vasoactive medication; before (tv0) and after (tv1) volume administration; before (tb0) and after (tb1) blood administration, (FFP, PLT).

At each timepoint adequate focus depth and contrast were noticed. Three steady images of 6 seconds were acquired and recorded on a device controller based on a powerful medical grade computer which is used for image storage and analysis.

Additionally macrocirculatory measurements were obtained at the same timepoints. Hemodynamic variables, temperature, blood gas, INVOS, StO2, laboratory findings and standart therapy were recorded. Additionally intubation time, ICU stay, hospital stay, ICU readmission, morbidity and mortality were studied.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Primary Completion: 2014-11
• Status Verified: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients undergoing coronary artery bypass grafting (CABG)

Exclusion Criteria

• previous heart and oral surgery
• age below 18 years,
• emergency surgery
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
functional capillary density	moment of measurement	functional capillary density is expected to be lower in the cryaloide group

Secondary Outcome Measures

Name	Time	Method
percentage perfused density	time of measurement	a higher percentage of perfused vessel density is expected in the blood group

Trial Locations

Locations (1)

Acıbadem University Hospital; 🇹🇷 Istanbul, Turkey