Echocardiography With Bubble Test for Tip Location of Central Venous Catheters

February 2, 2024 updated by: Dr.ssa Gabriella Arlotta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Transthoracic Echocardiography With Bubble Test for Tip Location of Central Venous Catheters: a "Push to Bubble" Time Analysis

The goal of this prospective observational study is to test the accuracy of the transthoracic echocardiography with bubble test to verify the location of the tip of the central venous catheter in patients undergoing cardiac surgery procedures. The main questions it aims to answer are:

Is there a difference in time elapsed between the injection of a saline solution (echogenic contrast) through a central venous catheter and the visualization of micro bubbles in right atrium ("push to bubbles" time) with transthoracic echocardiography, when the catheter tip is placed in four different positions identified by transesophageal echocardiography?
Is there a difference in time for the right atrium to be completely filled by bubbles after saline injection in a central venous catheter with the tip placed in four different positions identified by transesophageal echocardiography?
In what percentage of patients the acoustic window is good enough to evaluate "push to bubbles" time?
Is there a difference in "push to bubbles" time between different echocardiographic projections?
Is the bubbles flow laminar or turbulent in the four different positions?
Is there a relation between "push to bubble" time and heart rate, blood pressure, pulmonary artery pressure, central venous pressure and cardiac output measured through a pulmonary artery catheter?

Participants will require simultaneously a central venous catheter and an intraoperative transesophageal echocardiography.

Study Overview

Status

Not yet recruiting

Conditions

Cardiac Surgery Patient

Intervention / Treatment

Diagnostic test: Transthoracic echocardiography for central venous catheter tip location

Detailed Description

The placement of central vascular access devices (VADs), with cervical-thoracic or femoral insertion (such as CICC, Central Inserted Central Catheter, and FICC, Femoral Inserted Central Catheter), as well as peripheral insertion (PICC, Peripherally Inserted Central Catheter), is a common procedure for patients admitted to the Intensive Care Unit and for patients undergoing major surgery or prolonged infusion therapy.

To reduce the incidence of complications related to improper positioning of the central venous catheter, the tip should be positioned in the lower part of the superior vena cava or in the upper part of the right atrium near the cavo-atrial junction, identified by the crista terminalis.

Among the methods used to verify the correct tip placement, the intracavitary ECG method is strongly recommended by various international guidelines, and its use has been widely validated in terms of safety, efficacy, and accuracy. However, the intracavitary ECG method, based on the principle that the appearance of a high P-wave indicates the proximity of the tip to the cavo-atrial junction, has limitations when it comes to patients with non-sinus rhythm. Recent studies are validating the use of modified intracavitary ECG in patients with atrial fibrillation, but in other cases where a P-wave is not visible, the method is not applicable.

Various methods for ultrasound-guided placement and confirmation of the final tip position have been developed, also because the chest X-ray performed at the patient's bedside has proven to be a less accurate method due to the lack of definite findings of the cavo-atrial junction.

Transesophageal echocardiography (TEE), while being the method of choice as it allows direct visualization of the cavo-atrial junction and, therefore, the real position of both the guidewire and the tip of the catheter at the end of placement, remains an invasive method that is difficult to perform outside of cardiac operating rooms.

Transthoracic echocardiography may allow for the direct visualization of the tip of the VAD inside the heart chambers or indirectly assessing the tip's position by injecting echogenic contrast. Echogenic contrast refers to a rapid bolus of 5-20 ml of 0.9% saline solution, with or without the addition of 1 ml of air, vigorously shaken to create micro bubbles that can be easily visualized during the echocardiographic exam. The bolus is injected into the VAD once it has been positioned, and the micro bubbles are visualized in the right atrium, using transthoracic echocardiography. In nearly all studies, the VAD is considered in the correct position if the micro bubbles appear in the atrium within 2 seconds of injection ("push to bubble" time); otherwise, it is not considered correctly positioned if the bubbles appear after 2 seconds, but in one study, the adequate time was considered to be less than 500 ms. In almost all echocardiography studies, however, the reference method used to evaluate and confirm the VAD tip position has been chest radiography, which has been proven to be a less accurate method; moreover, literature shows significant variations in the indicative times for the visualization of micro bubbles that suggest incorrect position (range 0.5-2 seconds).

In this context, it could be useful to determine accurately if different "push to bubble" times are indicative for different positions of the VAD tip. For this purpose, the echogenic contrast (10 ml of 0,9% saline solution with the addition of 1 ml of air vigorously shaken to create micro bubbles) will be injected in the distal lumen of a VAD, whose tip is positioned in four different points, identified with using transesophageal echocardiography and the time from the contrast injection to the visualization of the bubbles in right atrium will be recorded using transthoracic echocardiography.

The four positions in which the catheter tip will be placed are: right atrium, cavo-atrial junction (CAJ), at 4 centimeters proximal to the CAJ in superior vena cava and at 8 centimeters to the CAJ. The catheter tip positions in right atrium and at CAJ will be directly evaluated using 2D and 3D transesophageal echocardiography, the other positions will be obtained moving the catheter back 4 and 8 centimeters from the CAJ. The transthoracic echocardiography will be carried out always by the same cardiologist trained in echocardiography unaware of the purpose of the study. The time measurements will be carried out always by the same cardiac anaesthesiologist, trained in echocardiography, unaware of the different catheter tip positions.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Temistocle Taccheri
Phone Number: +390630154848
Email: temistocle.taccheri@policlinicogemelli.it

Study Contact Backup

Name: Gabriella Arlotta
Phone Number: +390630154848
Email: gabriella.arlotta@policlinicogemelli.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The study will enroll patients of both sexes, aged> 18 years, with cardiovascular disease, who must undergo cardiac surgery

Description

Inclusion Criteria:

age > 18 years
written informed consent from the patient
intra-operative need for a central venous catheterization via the supra/infra clavicular right veins (centrally inserted central catheter, CICC)
indication to intra-operative Trans Esophageal Ultrasound (TEE) based on American Society of Anesthesiologists (ASA)

Exclusion Criteria:

contraindications to TEE based on American Society of Anesthesiologists (ASA) recommendations (esophageal or gastric diseases or previous surgery)
emergency procedures
central VAD already placed
need for a CICC via supra/infra clavicular left veins
need for a femorally inserted central catheter (FICC)
need for a peripherally inserted central catheter (PICC)
tricuspid valve regurgitation
hemodynamic instability/ presence of an intra-aortic ballon pump (IABP)
absence of septal atrial defect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent cardiac surgery with need for a central venous catheter Patients underwent cardiac surgery with need for a central venous catheter and indication to intraoperative trans esophageal echocardiography	Diagnostic test: Transthoracic echocardiography for central venous catheter tip location Measure of time between injection of echographic contrast in the distal lumen of a central venous catheter, inserted via supra/infra clavicular right veins, and visualization, using transthoracic echocardiography, of micro bubbles in right atrium with the catheter tip positioned under transesophageal ultrasound control in four different positions: right atrium, cavo-atrial junction (CAJ), at 4 centimeters proximal to CAJ, in superior vena cava and at 8 centimeters proximal to CAJ

Group / Cohort

Intervention / Treatment

Patients underwent cardiac surgery with need for a central venous catheter

Patients underwent cardiac surgery with need for a central venous catheter and indication to intraoperative trans esophageal echocardiography

Diagnostic test: Transthoracic echocardiography for central venous catheter tip location

Measure of time between injection of echographic contrast in the distal lumen of a central venous catheter, inserted via supra/infra clavicular right veins, and visualization, using transthoracic echocardiography, of micro bubbles in right atrium with the catheter tip positioned under transesophageal ultrasound control in four different positions: right atrium, cavo-atrial junction (CAJ), at 4 centimeters proximal to CAJ, in superior vena cava and at 8 centimeters proximal to CAJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 1: right atrium, using subcostal 4-chamber view Time Frame: Immediately after the induction of anesthesia, placement of transesophageal probe and insertion of a central venous catheter. The video recorded will be analyzed immediately after the end of the procedure	After the insertion of a central venous catheter in the supraclavicular right area by ultrasound guidance and direct Seldinger technique, under transesophageal ultrasound control, the catheter tip will be placed in right atrium, 2 cm below the CAJ; the echographic contrast will be injected through the proximal end of the catheter connected, via an Arrow-Johans adapter (Teleflex) and a dedicated ECG cable (Teleflex), to the transthoracic ultrasound machine. The video with the micro bubbles injected will be recorded by a cardiologist expert in echocardiography, unaware of the purpose of the study, using a subcostal 4-chamber view. Later a cardiac anesthesiologist, unaware of the purpose of the position of the catheter, will measure the time elapsed between the first positive wave created by the contrast injection on the intracavitary ECG recorded by the transthoracic ultrasound machine and the time in which the bubbles will appear in the right atrium.	Immediately after the induction of anesthesia, placement of transesophageal probe and insertion of a central venous catheter. The video recorded will be analyzed immediately after the end of the procedure
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 1: right atrium, using subcostal bicaval view Time Frame: Immediately after the video recorded with the catheter tip placed in right atrium using subcostal 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed in right atrium using subcostal bicaval view	Immediately after the video recorded with the catheter tip placed in right atrium using subcostal 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 1: right atrium, using apical 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip placed in right atrium using subcostal bicaval view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed in right atrium using apical 4-chamber view	Immediately after the video recorded with the catheter tip placed in right atrium using subcostal bicaval view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 2: cavo-atrial junction (CAJ), using subcostal 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip placed in right atrium using apical 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at the CAJ, using subcostal 4-chamber view	Immediately after the video recorded with the catheter tip placed in right atrium using apical 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 2: cavo-atrial junction (CAJ), using subcostal bicaval view Time Frame: Immediately after the video recorded with the catheter tip placed at the CAJ using subcostal 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at the CAJ, using subcostal bicaval view	Immediately after the video recorded with the catheter tip placed at the CAJ using subcostal 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 2: cavo-atrial junction (CAJ), using apical 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip placed at the CAJ using subcostal bicaval view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at the CAJ, using apical 4-chamber view	Immediately after the video recorded with the catheter tip placed at the CAJ using subcostal bicaval view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 3: at 4 centimeters proximal to CAJ in superior vena cava, using subcostal 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip placed at the CAJ using apical 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at , 4 centimeters proximal to CAJ in superior vena cava, using subcostal 4-chamber view	Immediately after the video recorded with the catheter tip placed at the CAJ using apical 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 3: at 4 centimeters proximal to CAJ in superior vena cava, using subcostal bicaval view Time Frame: Immediately after the video recorded with the catheter tip at 4 centimeters proximal to CAJ, in superior vena cava, using subcostal 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at 4 centimeters proximal to CAJ in superior vena cava, using subcostal bicaval view	Immediately after the video recorded with the catheter tip at 4 centimeters proximal to CAJ, in superior vena cava, using subcostal 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 3: at 4 centimeters proximal to CAJ in superior vena cava, using apical 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip at 4 centimeters proximal to CAJ, in superior vena cava, using subcostal bicaval view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at 4 centimeters proximal to CAJ in superior vena cava, using apical 4-chamber view	Immediately after the video recorded with the catheter tip at 4 centimeters proximal to CAJ, in superior vena cava, using subcostal bicaval view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 4: at 8 centimeters proximal to CAJ, using subcostal 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip at 4 centimeters proximal to the CAJ, in superior vena cava, using apical 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at 8 centimeters proximal to the CAJ, using subcostal 4-chamber view	Immediately after the video recorded with the catheter tip at 4 centimeters proximal to the CAJ, in superior vena cava, using apical 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 4: at 8 centimeters proximal to CAJ, using subcostal bicaval view Time Frame: Immediately after the video recorded with the catheter tip at 8 centimeters, using subcostal 4-chamber view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at 8 centimeters proximal to the CAJ, using subcostal bicaval view	Immediately after the video recorded with the catheter tip at 8 centimeters, using subcostal 4-chamber view
Difference in "push to bubbles" time recorded with the catheter tip placed in four different positions by three different ultrasound views; measure in position 4: at 8 centimeters proximal to CAJ, using apical 4-chamber view Time Frame: Immediately after the video recorded with the catheter tip at 8 centimeters, using subcostal bicaval view	With the procedure described above, the "push to bubble" time will be measured with the catheter tip placed at 8 centimeters proximal to the CAJ, using apical 4-chamber view	Immediately after the video recorded with the catheter tip at 8 centimeters, using subcostal bicaval view

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Gabriella Arlotta, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

5762 (DUMC old IRB #)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Echocardiography With Bubble Test for Tip Location of Central Venous Catheters

Transthoracic Echocardiography With Bubble Test for Tip Location of Central Venous Catheters: a "Push to Bubble" Time Analysis

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Contact Backup

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Estimated)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Cardiac Surgery Patient

Clinical Trials on Transthoracic echocardiography for central venous catheter tip location

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