Preoperative Pocket Echocardiography Trial (POPPET)

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.

Study Overview

• Status: Completed
• Conditions: Echocardiography; Preoperative Period
• Intervention / Treatment: Device: Full TTE; Device: GE Vscan

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Acton
    • London, East Acton, United Kingdom, W12 0HS
      • Hammersmith Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No consent or withdrawal of consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full TTE; Full echocardiogram.	Device: Full TTE; Full transthoracic echocardiogram, with Doppler.
Experimental: VScan; Handheld echocardiogram.	Device: GE Vscan; Handheld echo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Petros Nihoyannopoulos, Professor, Imperial College London

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pre-operative; transthoracic echocardiography; handheld
• Other Study ID Numbers: 15/YH/0333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No