Preoperative Pocket Echocardiography Trial (POPPET)
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| ClinicalTrials.gov Identifier: NCT02589808 |
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Recruitment Status :
Completed
First Posted : October 28, 2015
Last Update Posted : February 22, 2016
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preoperative Period Echocardiography | Device: Echocardiography | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 76 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Preoperative Pocket Echocardiography Trial |
| Study Start Date : | July 2015 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2016 |
| Arm | Intervention/treatment |
|---|---|
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Echocardiography
Cardiac ultrasound scan.
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Device: Echocardiography
Pocket ultrasound device.
Other Name: GE Vscan |
- Preoperative echocardiographic assessment with a handheld ultrasound unit (GE VScan) of adult, non-cardiac, surgical patients. The level of agreement between the handheld study and a full diagnostic echocardiogram is to be assessed. [ Time Frame: Handheld study to be performed 10 minutes prior to diagnostic study ]Preoperative echocardiographic assessment with a handheld ultrasound unit (GE VScan) of adult, non-cardiac, surgical patients. The level of agreement between the handheld study and a full diagnostic echocardiogram is to be assessed. Both studies will be performed by skilled operators blinded to each others findings.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Adult surgical (non-cardiac) patients referred preoperatively for resting transthoracic echocardiogram
Exclusion Criteria:
• No consent or withdrawal of consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589808
| United Kingdom | |
| Hammersmith Hospital | |
| London, East Acton, United Kingdom, W12 0HS | |
| Principal Investigator: | Petros Nihoyannopoulos, Professor | Imperial College London |
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT02589808 History of Changes |
| Other Study ID Numbers: |
15/YH/0333 |
| First Posted: | October 28, 2015 Key Record Dates |
| Last Update Posted: | February 22, 2016 |
| Last Verified: | February 2016 |
Keywords provided by Imperial College London:
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pre-operative transthoracic echocardiography handheld |