NCT02589808

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

September 29, 2015

Results QC Date

August 12, 2019

Last Update Submit

September 30, 2019

Conditions

Keywords

pre-operativetransthoracic echocardiographyhandheld

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Full TTE

EXPERIMENTAL

Full echocardiogram.

Device: Full TTE

VScan

EXPERIMENTAL

Handheld echocardiogram.

Device: GE Vscan

Interventions

Full TTEDEVICE

Full transthoracic echocardiogram, with Doppler.

Full TTE
GE VscanDEVICE

Handheld echo.

VScan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • No consent or withdrawal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, East Acton, W12 0HS, United Kingdom

Location

Results Point of Contact

Title
Petros Nihoyannopoulos
Organization
Imperial College

Study Officials

  • Petros Nihoyannopoulos, Professor

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 28, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations