AzTrials
AzTrials

Ischemic Heart DiseaseNCT01616979

Saline Bag and TEE During Cardiac Displacement

An observational study of Ischemic Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Ischemic Heart Disease
What is being tested?
placing saline bag during cardiac displacement
Type of treatment
Surgery or procedure
How many people
13 participants
Where
1 siteSouth Korea
Study dates
Mar 2008to Mar 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: elective OPCAB surgery patients

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Intraoperative exclusion criteria for the study are patients with inadequate RWM monitoring, defined as fewer than 14 out of the 17 segment LV model, except for the apex, are readable using the integrated ME and TG TOE images immediately after TOE probe insertion and patients who required cardiopulmonary bypass due to severe myocardial ischaemia and haemodynamic instability during cardiac displacement.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Konkuk University Medical Center

    Seoul, 143729

Other trials in South Korea

About this study

Official title: Placing a Saline Bag Underneath the Heart Enhances Transgastric Transoesophageal Echocardiographic Imaging During Cardiac Displacement for Off-pump Coronary Artery Bypass Surgery

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).

Read the detailed description

A multi-plane TOE probe (6T, GE Healthcare, Milwaukee, WI, USA) is inserted immediately after anaesthesia induction. One of authors (anaesthesiologist) performs the routine intraoperative TOE study, including analysis of RWM, using the 17-segment LV model 11-14 and a TOE imaging system (Vivid 7, GE Healthcare, Milwaukee, WI, USA) and the following six TOE images: ME 4-chamber (4-CH), ME 2-chamber (2-CH), ME long-axis (LAX), mid and basal TG short-axis (SAX), and TG LAX.

For the present study, the three-beat clips of two-dimensional (2D) mid-oesophageal (ME) views, including ME 4-chamber (ME 4-CH), ME 2-chamber (ME 2-CH), and ME long-axis (ME-LAX) views, and those of transgastric (TG) views, including the basal TG short-axis (basal TG SAX), mid short-axis (mid TG SAX), and TG-LAX views, are stored on the hard disc of the TOE imaging system as digital recordings at each of the following time points:

(i) T-control: during harvesting the vascular grafts after sternotomy. (ii) T-displaced: after completion of cardiac displacement and stabilisation for the distal graft construction to the LCX territory by stabilisers to maintain both maximal surgical access and minimal haemodynamic instability under the guidance of haemodynamic monitoring.

(iii) T-saline bag: after placing the saline bag underneath the displaced heart and further fine positioning.

Using a program (EchoPAC, GE Healthcare, Milwaukee, WI,), a cardiologist, who is unaware of the aim of the present study, undertook a postoperative off-line analysis of the stored images to determine the following data under T-control, T-displaced, and T-saline bag conditions: 1) NRS out of a LV 17-segment model using ME views only and integrated ME+TG views; 2) NRS out of five LV segments in the LCX territory including basal inferolateral, mid-inferolateral, basal anterolateral, mid anterolateral, and apical lateral segments using ME views only and integrated ME + TG views; 3) NRS out of six LV segments in the TG basal SAX view, including basal anterior, basal anterolateral, basal anteroseptal, basal inferior, basal inferolateral, and basal inferoseptal segment; 4) NRS out of six LV segments in the TG mid-SAX view, including mid-anterior, mid-anterolateral, mid-anteroseptal, mid-inferior, mid-inferolateral, and mid-inferoseptal segments; and 5) the incidence (%) of inadequate RWM monitoring, defined as fewer than 14 out of the 17 segment model (except for the apex) were readable, using the integrated ME + TG views.

Each LV segment is defined as readable/unreadable when more than 50% of the endocardial and epicardial borders were visible/invisible or more than 90% of endocardial border was visible or 10% was invisible.

The primary objectives of the present study are to evaluate the efficacy of placing a saline filled glove in enhancing TOE's ability for global and regional LV RWM monitoring and to determine NRS out of the LV 17-segment model using ME views alone and integrated ME+TG views.

As secondary objectives, NRS out of five LV segments in the LCX territory by using ME views alone vs. integrated ME+TG views as well as NRS out of six LV segments in the TG SAX view are determined, to confirm whether TG TOE imaging can be applied for regional LV RWM monitoring during cardiac displacement. The incidence (%) of inadequate RWM monitoring in 17-segment model using ME views alone vs. integrated ME+TG views is also compared to determine whether the possible increase in NRS facilitates the adequate TOE imaging.

Being tested
placing saline bag during cardiac displacement
Keywords
Off-pump coronary artery bypass surgery, Transesophageal echocardiography
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placing saline bag during cardiac displacementProcedure or surgery

    Also called displacing the heart for LCX grafting, placing the saline bag underneath the displaced heart

    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.

Study groups in NCT01616979
Study groupRoleWhat they receive
OPCAB surgeryFifteen elective OPCAB surgery patients who undergo grafting in the left circumflex artery territory due to three-vessel disease
Receives: Procedure: placing saline bag during cardiac displacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart

Secondary outcomes (3)
  1. NRS out of five LV segments in the LCX territory by using ME views alone vs. integrated ME+TG views

    NRS out of five LV segments in the LCX territory including basal inferolateral, mid-inferolateral, basal anterolateral, mid anterolateral, and apical lateral segments using ME views only and integrated ME + TG views

    Measured: T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart

  2. NRS out of six LV segments in the TG SAX view by using ME views alone vs. integrated ME+TG views

    NRS out of six LV segments in the TG mid-SAX view, including mid-anterior, mid-anterolateral, mid-anteroseptal, mid-inferior, mid-inferolateral, and mid-inferoseptal segments by using ME views alone vs. integrated ME+TG views

    Measured: T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart

  3. The incidence (%) of inadequate RWM monitoring in 17-segment model using ME views alone vs. integrated ME+TG views

    the incidence (%) of inadequate RWM monitoring, defined as fewer than 14 out of the 17 segment model (except for the apex) were readable, using ME views alone vs. integrated ME+TG views

    Measured: T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2012 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616979
Sponsor's protocol ID
KUH-1160037
Status last verified
Aug 2012
First submitted
7 Jun 2012
Last updated
20 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease, run by Konkuk University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Number of readable segments (NRS) in a 17-segment LV model during cardiac displacement for OPCAB surgery (time frame: T-control, T-after displacing heart for left circumflex artery grafting, T-after placing saline bag underneath the displaced heart). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in