Echocardiography With Bubble Test for Tip Location of Central Venous Catheters

NCT06243445 | Completed

• 1 other identifier: 5762
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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?
2. 2.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?
3. 3.In what percentage of patients the acoustic window is good enough to evaluate "push to bubbles" time?
4. 4.Is there a difference in "push to bubbles" time between different echocardiographic projections?
5. 5.Is the bubbles flow laminar or turbulent in the four different positions?
6. 6.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?

Conditions

Cardiac Surgery Patient

Keywords

central venous catheter tip location; transthoracic echocardiography; bubble test

Outcome Measures

Primary Outcomes (12)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (62)

• Difference in time for the right atrium to be completely filled by micro bubbles; measure with the catheter tip placed in position 1: right atrium, using subcostal 4-chamber view

  Immediately after measuring "push to time" in the video recorded with the catheter tip in right atrium, using subcostal 4-chamber view

• Difference in time for the right atrium to be completely filled by micro bubbles; measure with the catheter tip placed in position 1: right atrium, using subcostal bicaval view

  Immediately after measuring "push to time" in the video recorded with the catheter tip placed in right atrium using subcostal bicaval view

• Difference in time for the right atrium to be completely filled by micro bubbles; measure with the catheter tip placed in position 1: right atrium, using apical 4-chamber view

  Immediately after measuring "push to time" in the video recorded with the catheter tip placed in right atrium, using apical 4-chamber view

• Difference in time for the right atrium to be completely filled by micro bubbles; measure with the catheter tip placed in position 2: cavo-atrial junction (CAJ), using subcostal 4-chamber view

  Immediately after measuring "push to time" in the video recorded with the catheter tip placed at cavo-atrial junction (CAJ), using subcostal 4-chamber view

• Difference in time for the right atrium to be completely filled by micro bubbles; measure with the catheter tip placed in position 2: cavo-atrial junction (CAJ), using subcostal bicaval view

  Immediately after measuring "push to time" in the video recorded with the catheter tip placed at cavo-atrial junction (CAJ), using subcostal bicaval

Study Arms (1)

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

Interventions

Transthoracic echocardiography for central venous catheter tip location DIAGNOSTIC_TEST

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

Patients underwent cardiac surgery with need for a central venous catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Gabriella Arlotta

Roma, 00168, Italy

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Gabriella Arlotta

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: November 27, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

IT (1)