Saline Bag and TEE During Cardiac Displacement
Placing a Saline Bag Underneath the Heart Enhances Transgastric Transoesophageal Echocardiographic Imaging During Cardiac Displacement for Off-pump Coronary Artery Bypass Surgery
1 other identifier
observational
13
1 country
1
Brief Summary
During cardiac displacement for off-pump coronary artery bypass(OPCAB) surgery, the presence of air underneath the displaced heart compromises the transgastric (TG) window for transoesophageal echocardiography(TOE). The investigators hypothesised that placing a saline-filled glove would enhance TG transmission of ultrasound and facilitate TOE imaging for monitoring left-ventricular regional wall motion (LV-RWM). For left circumflex coronary artery (LCX) grafting in OPCAB surgery (n=13), mid-oesophageal (ME) and TG TOE images are recorded before cardiac displacement (T control), after displacing and stabilising the heart (T-displaced), and after placing a saline bag (saline-filled surgical glove) underneath the displaced heart (T-saline bag). Following data are determined by integrated TG and ME TOE views (ME+TG) at T-control, T-displaced and T-saline bag: number of readable segments (NRS) in a 17-segment model; NRSs in basal and mid-TG short axis views; NRS in 5-LV segments of the LCX territory; the incidence of inadequate monitoring of LV-RWM (NRS \< 14/16 except for the apex in 17-segment model).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedAugust 20, 2012
August 1, 2012
3.9 years
June 7, 2012
August 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of Number of readable segments (NRS) in a 17-segment LV model during cardiac displacement for OPCAB surgery
NRS in a 17-segment LV model, determined by midesophageal alone(ME) vs. integrated ME and transgastric (TG) TOE views (ME+TG) are determined at following time points and their changes are analyzed: T-control, during harvesting the vascular grafts after sternotomy; T-displaced, after completion of cardiac displacement and stabilisation for the LCX territory grafting; T-saline bag, after placing the saline bag underneath the displaced heart and further fine positioning.
T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart
Secondary Outcomes (3)
NRS out of five LV segments in the LCX territory by using ME views alone vs. integrated ME+TG views
T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart
NRS out of six LV segments in the TG SAX view by using ME views alone vs. integrated ME+TG views
T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart
The incidence (%) of inadequate RWM monitoring in 17-segment model using ME views alone vs. integrated ME+TG views
T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart
Study Arms (1)
OPCAB surgery
Fifteen elective OPCAB surgery patients who undergo grafting in the left circumflex artery territory due to three-vessel disease
Interventions
For grafting to LCX territory, the heart is displaced using positioner and a suction-type epicardial stabiliser is applied to the target area. The degree of cardiac displacement and the LV compression by stabilisers are adjusted for maximal surgical access and minimal haemodynamic instability.
Eligibility Criteria
elective OPCAB surgery patients
You may qualify if:
- three-vessel disease during a week at a tertiary university hospital participated in this prospective observational study after we obtained institutional review board approval (KUH1160037) and written consent.
You may not qualify if:
- patients with oesophageal pathology (such as spasm, stricture, laceration, perforation, and diverticula),
- diaphragmatic hernia,
- history of extensive radiation to the mediastinum and upper gastrointestinal bleeding are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, 143729, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tae-Yop Kim, MD PhD
Konkuk University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 12, 2012
Study Start
March 1, 2008
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
August 20, 2012
Record last verified: 2012-08