Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02589808
Other study ID # 15/YH/0333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date February 2016

Study information

Verified date September 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare findings using a handheld ultrasound device (GE VScan) with those using a diagnostic ultrasound machine in adult patients referred for transthoracic echo (TTE), prior to non-cardiac surgery at Hammersmith Hospital, London.

The handheld TTE (VTTE) will follow the standard Hammersmith Hospital diagnostic TTE (DTTE) protocol (with the exception of spectral Doppler) and will be reported on a simple 'tick box' form. A different echocardiographer will then perform and report the DTTE as per routine practice. The results from VTTE and DTTE will be directly compared. The echocardiographers performing the VTTE and DTTE are all fully accredited in diagnostic TTE and will be blinded to each others findings.

The study aims to recruit a total of 96 patients with an anticipated study completion date of November 2015.


Description:

Handheld echocardiography has become a practical reality with the development of small and highly portable devices. The GE VScan is one such device and a number of studies have examined its diagnostic capabilities in different clinical settings however, no study has examined its capability for screening non-cardiac surgical patients in the preoperative setting. If VTTE could be shown to safely screen patients preoperatively then there is potential to save time and money. DTTE is more costly than VTTE and there are often delays in performing DTTE prior to surgery.

Adult patients > 17 years old who are referred for a preoperative TTE prior to non-cardiac surgery (elective or emergency procedures) are eligible for recruitment. Once an eligible patient is identified verbal and written consent to participate will be obtained.

VTTE will be performed by one of six accredited echocardiographers working in Hammersmith Hospital Echocardiography Department. Based on pilot data and previously published studies it is estimated the VTTE will take between 3 and 7 minutes. The VTTE is reported on a 'tick box' form with the findings separated into significant pathology (red zone) and insignificant pathology or normal findings (black zone).

DTTE will then be performed by a different echocardiographer and a written report prepared as per normal practice. The written DTTE report will be converted to a 'tick box' report enabling direct comparison of VTTE and DTTE.

The primary aim is to assess the ability of the VTTE to detect significant pathology identified on DTTE.

A proportion of DTTE and VTTE will be re-rated to obtain a measure of inter- and intra- observer variability.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

• Adult surgical (non-cardiac) patients referred preoperatively for resting transthoracic echocardiogram

Exclusion Criteria:

• No consent or withdrawal of consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Full TTE
Full transthoracic echocardiogram, with Doppler.
GE Vscan
Handheld echo.

Locations

Country Name City State
United Kingdom Hammersmith Hospital London East Acton

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Same Results With GE VScan and Full Transthoracic Echocardiogram Number of participants who had the same results with both diagnostic device (GE VScan and full transthoracic echocardiogram) 30min
See also
  Status Clinical Trial Phase
Completed NCT04083924 - Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum N/A
Recruiting NCT05778500 - Algorithms to Improve the Accuracy of the Echocardiographic Report
Completed NCT04925245 - Clinical Reminder to Improve Appropriateness of Echocardiography N/A
Completed NCT02000492 - Frequent Ballgames Training for 9-11 Year Old Schoolchildren N/A
Recruiting NCT05055089 - Short- and Medium-term Results of New Generation Aortic
Completed NCT04334733 - The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children N/A
Recruiting NCT06106178 - A Novel Serious Game as an Alternative for Teaching Basic Point-of-Care Transthoracic Echocardiography Skills N/A
Completed NCT05103189 - 4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension N/A
Completed NCT03221205 - Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients N/A
Not yet recruiting NCT03638245 - Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
Recruiting NCT04395014 - Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.
Withdrawn NCT03133962 - Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter N/A
Completed NCT04366453 - Evaluation of LVEF by a New Automatic Evaluation Tool in a Pocket Ultrasound Scanner N/A
Recruiting NCT05462301 - Normal Reference Range for Neonatal Echocardiography
Withdrawn NCT04810520 - Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians
Recruiting NCT03464591 - Cardiac Speckle Tracking Myocardial Strain Balance
Completed NCT04419662 - Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures Phase 4
Completed NCT00730964 - A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. Phase 4
Completed NCT06330103 - Efficacy of AI EF Screening by Using Smartphone Application Recorded PLAX View Cardiac Ultrasound Video Clips N/A
Not yet recruiting NCT05306730 - Echocardiography by Non-cardiologist in Early Management of Patients With Chest Pain N/A