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Preoperative Pocket Echocardiography Trial

Preoperative Pocket Echocardiography Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02589808
Acronym
POPPET
Enrollment
76
Registered
2015-10-28
Start date
2015-07-31
Completion date
2016-02-29
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Preoperative Period

Keywords

pre-operative, transthoracic echocardiography, handheld

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.

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.

Interventions

DEVICEFull TTE

Full transthoracic echocardiogram, with Doppler.

DEVICEGE Vscan

Handheld echo.

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

• No consent or withdrawal of consent.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Same Results With GE VScan and Full Transthoracic Echocardiogram30minNumber of participants who had the same results with both diagnostic device (GE VScan and full transthoracic echocardiogram)

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Echocardiography
Cardiac ultrasound scan. Echocardiography: Pocket ultrasound device.
76
Total76

Baseline characteristics

CharacteristicEchocardiography
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
36 Participants
Age, Categorical
Between 18 and 65 years
40 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United Kingdom
76 participants
Sex: Female, Male
Female
56 Participants
Sex: Female, Male
Male
20 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 76
other
Total, other adverse events
0 / 76
serious
Total, serious adverse events
0 / 76

Outcome results

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)

Time frame: 30min

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
EchocardiographNumber of Participants With Same Results With GE VScan and Full Transthoracic Echocardiogram66 Participants
p-value: 0.0005Kappa

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026