Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001336370
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
20/09/2017
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utility of non-invasive cardiac output measurements in adult hospital patients with low blood pressure during Medical Emergency Team review.
Scientific title
Utility of non-invasive cardiac output measurements in hypotensive patients during Medical Emergency Team review.
Secondary ID [1] 292882 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension 304726 0
sepsis 304745 0
Condition category
Condition code
Cardiovascular 304045 304045 0 0
Other cardiovascular diseases
Infection 304075 304075 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants are adult in-patients at a tertiary Australian hospital. The monitoring system consists of a monitor with a screen and cables which attach to a finger-cuff containing a bladder. This finger-cuff is similar to a blood pressure cuff and is designed to fit the index or middle finger, which inflates periodically and measures blood pressure and cardiac output. The monitor can calculate complex haemodynamic parameters from the input of information like the height, sex, weight and central venous pressure of the patient. This monitor is not standard equipment at the medical emergency team review, and is used in some patients undergoing surgery and has been studied in emergency department patients. Therefore this is a non-invasive intervention for the purposes of applying a monitoring system in order to observe the cardiac index.
An appropriately sized finger-cuff is applied to the participant's finger. This is done by the trial investigator who is either a registered nurse on the Medical Emergency Team (MET) service or a doctor trained in the use of this monitoring system. The application of the monitor is aimed to commence prior to any resuscitation, however does not impede it. The measurement of interest is the cardiac output and index which are recorded on to the monitor. The monitor screen is covered with a flap as the parameters are not intended for observation by the treating team during the MET. Monitoring to be continued throughout the MET until it is stood down or ceased at 60 minutes from the first application of the monitor, whichever is earlier.
Intervention code [1] 299122 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303373 0
Cardiac index obtained by direct observation from the EV1000 Cardiac output monitor
Timepoint [1] 303373 0
Prior to commencement of resuscitation
Secondary outcome [1] 338827 0
Cardiac index obtained by direct observation from the EV1000 Cardiac output monitor
Timepoint [1] 338827 0
At the end of MET call or 60 minutes from the first application of the cardiac output monitor

Eligibility
Key inclusion criteria
Adult, in-hospital patient
MET call for hypotension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac arrest
Imminently dying
Patient who has a "not for resuscitation" care plan

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
the primary outcome would be assessed with descriptive statistics, which is the cardiac index over the course of monitoring.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/03/2017
Date of last participant enrolment
Anticipated
4/02/2018
Actual
30/11/2017
Date of last data collection
Anticipated
4/02/2018
Actual
1/02/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 9022 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 17498 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 297508 0
Charities/Societies/Foundations
Name [1] 297508 0
The Canberra Hospital Foundation
Country [1] 297508 0
Australia
Funding source category [2] 297511 0
Hospital
Name [2] 297511 0
Intensive Care Department Research Fund - The Canberra Hospital
Country [2] 297511 0
Australia
Primary sponsor type
Individual
Name
Siddharth Goswami
Address
ICU, C1W
Sydney Children's Hospital
High Street, Randwick 2031
NSW
Country
Australia
Secondary sponsor category [1] 296515 0
Individual
Name [1] 296515 0
Frank Van Haren
Address [1] 296515 0
ICU executive offices
The Canberra hospital
Level 3, building 2,
77 Yamba Drive
Garran ACT 2605
Country [1] 296515 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298607 0
ACT Health Low Risk Subcommittee Committee (LRSC)
Ethics committee address [1] 298607 0
Research Ethics and Governance Office
ACT Government Health Directorate Research Office, Building 10 Level 6
Canberra Hospital |Yamba Drive, GARRAN ACT 2605
Ethics committee country [1] 298607 0
Australia
Date submitted for ethics approval [1] 298607 0
01/12/2014
Approval date [1] 298607 0
02/02/2015
Ethics approval number [1] 298607 0
ETHLR.14.334

Summary
Brief summary
Patient's with severe infection can present with low blood pressure and require immediate treatment and sometimes cardiac output monitoring to understand how best to treat them. The primary purpose of this study is to understand their cardiac output prior to commencement of resuscitation on adult patients who have low blood pressure in hospital using a finger cuff which is non-invasive and previously shown to be validated in some patient populations. The aim of the study is to describe the range of cardiac output in patients who deteriorate in hospital. It is hoped that this will allow description of important subtypes who will benefit from specifically tailored therapies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77642 0
Dr Siddharth Goswami
Address 77642 0
ICU, C1W
Sydney Children's Hospital
High Street
Randwick 2031 NSW
Country 77642 0
Australia
Phone 77642 0
+61 2 93821919
Fax 77642 0
Email 77642 0
siddharth_goswami@hotmail.com
Contact person for public queries
Name 77643 0
Siddharth Goswami
Address 77643 0
ICU, C1W
Sydney Children's Hospital
High Street
Randwick 2031 NSW
Country 77643 0
Australia
Phone 77643 0
+61 2 93821919
Fax 77643 0
Email 77643 0
siddharth_goswami@hotmail.com
Contact person for scientific queries
Name 77644 0
Frank Van Haren
Address 77644 0
ICU executive offices
The Canberra hospital
Level 3, building 2,
77 Yamba Drive
Garran ACT 2605
Country 77644 0
Australia
Phone 77644 0
+61 2 62442222
Fax 77644 0
Email 77644 0
Frank.Vanharen@act.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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