Trial no.:	PACTR201703002141319	Date of Approval:	26/03/2017
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Cardiometry versus Transoesophageal Doppler for Peri-operative Haemodynamic Monitoring and Management in Pediatrics Undergoing Kasai operation

Official scientific title

Electrical Cardiometry Compared to Transoesophageal Doppler for Peri-operative Haemodynamic Monitoring and Fluid Management in Pediatrics Undergoing Kasai Operation

Brief summary describing the background and objectives of the trial

In recent years there have been increased efforts to improve the perioperative care of patients undergoing surgery under general or regional anesthesia. This has led to the emergence of Enhanced Recovery Programs (ERP). One element of ERP is intraoperative fluid management (IOFM). The aim of IOFM is to provide the patient with the correct amount of intravenous fluid during surgery and to avoid both fluid overload and hypoperfusion of organs, leading to delayed recovery. The use of safe, simple, non-invasive and cost-effective techniques of estimating stroke volume (SV) and cardiac output (CO) is important for IOFM as the Transoesophageal Doppler (TED) & Electrical Cardiometry (EC). Transoesophageal Doppler (TED) is a minimally invasive technology intended for use in moderate to high risk surgical or critical care patients, it consists of a monitor and a disposable esophageal probe. TED uses the Doppler principle whereby a transducer on the probe tip emits an ultrasound signal, which is reflected back to a second transducer on the probe tip by the moving red blood cells in the aorta. The software measures the stroke volume, using an internal calibration constant based on patient¿s age, weight and height. Electrical Cardiometry (EC) is a recently developed technology to measure the cardiac output. EC derive CO from measurements of Thoracic Electrical Bioimpedance (TEB), which is the electrical resistance to high frequency low amplitude current that is transmitted from electrodes placed on the upper and lower thorax. Originally, the Kubicek equation was used to calculate the CO from TEB which was later modified by Bernstein

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Extrahepatic biliary atresia, Transoesophageal Doppler, Electrical Cardiometry,Paediatrics

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Devices

Anticipated trial start date

01/12/2015

Actual trial start date

02/01/2016

Anticipated date of last follow up

08/04/2017

Actual Last follow-up date

12/04/2017

Anticipated target sample size (number of participants)

42

Actual target sample size (number of participants)

42

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomisation using a radomisation table created by a computer software program	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Transoesophageal Doppler (TED) group		perioperative	Following induction of anesthesia, 4 to 5.5 F central venous catheter placed ultrasound guided. Then, a 4 MHz, flexible TED probe specific for pediatric use passed orally in all patients into the mid-esophagus until aortic blood flow signals best identified before each measurement, The monitoring system used (CardioQp, Deltex medical, Chichester-UK)	21
Experimental Group	Electrical Cardiometry (EC) group		perioperative	Following induction of anesthesia, 4 to 5.5 F central venous catheter placed ultrasound guided. Then, Cardiometry was placed in all patients using four sensors applied to specific body sites and sensor cable connected to The monitor (Electrical Cardiometry monitor, ICON Cardiotronics, Inc., La Jolla, CA 92307; Osypka Medical GmbH, Berlin, Germany)	21

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Age: infants below 3 months. American Society of Anesthesiologists (ASA): grade I / II Surgery: hepatoportoenterostomy (Kasai operation)	Parent refusal. ASA < grade II. Anticoagulant therapy or history of bleeding tendency. Known congenital heart disease with haemodynamic consequences. Preoperative haemodynamic instability or catecholamine infusion. Oesophageal malformation.		30 Day(s)	100 Day(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

15/11/2015

faculty of medicine ethics comittee - Menoufia university

Ethics Committee Address
Street address	City	Postal code	Country
yaseen abdelghaffar	shebin elkom - menoufia governerate	23154	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	The primary goal of this study is to compare the (TED) with (EC) and investigate both relationship with one another and with the traditional central venous pressure (CVP) regarding haemodynamics and fluid management in paediatrics undergoing surgical hepatoportoenterostomy (Kasai operation)	at Baseline (after induction of anesthesia). Then, every hour till end of the surgery, During and after fluid challenge bolus

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
National liver institute - Menoufia University	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
National liver institute - Menoufia University	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	National liver institute - Menoufia University	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Khaled Ahmed Yassen	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt
Ashraf Mohammed Moustafa	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt
Osama Abd-Allah Elsharkawy	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt
Maha Lotfy Elsheikh	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt
Rasha Foaad Metawe Elshoney	yaseen abdelghaffar	shebin elkom - Menoufia	23154	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Khaled Yassen	kyassen61@hotmail.com	002-010-63080170	Yaseen Abdelghaffar
City	Postal code	Country	Position/Affiliation
Shebin Elkom - Menoufia	23154	Egypt	Professor and head of Anaesthesia department - National liver institute
Role	Name	Email	Phone	Street address
Public Enquiries	Rasha Foaad	rashafoaad@yahoo.com	00201092601200	Yaseen Abdelghaffar
City	Postal code	Country	Position/Affiliation
Shebin Elkom - Menoufia	23154	Egypt	assistant lecturer of anasthesia and intensive care
Role	Name	Email	Phone	Street address
Scientific Enquiries	Maha Lotfy	mahalotfy37@yahoo.com	0020482221729	Yaseen Abdelghaffar
City	Postal code	Country	Position/Affiliation
Shebin Elkom - Menoufia	23154	Egypt	lecturer of anasthesia and intensive care

REPORTING
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Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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