Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001373777 Date of Approval: 02/12/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Masimo® Plethysmograph Variability Index as a Tool for Assessment of Fluid Responsiveness in Elective Major Abdominal Surgeries
Official scientific title Masimo® Plethysmograph Variability Index as a Tool for Assessment of Fluid Responsiveness in Elective Major Abdominal Surgeries
Brief summary describing the background and objectives of the trial Transesophageal Doppler (TED) ultrasonography of the descending aorta could be a useful monitoring device that allows a continuous estimation of CO and facilitates the assessment of preload, afterload, and myocardial contractility by calculating advanced hemodynamic variables.Although TED can be considered as a safe technology, yet, some complications including minor trauma to the buccal cavity, transient vagal response during probe insertion, unintentional removal of a gastric tube during probe removal, epistaxis, and two cases of tracheal or bronchial probe misplacemen were reported. Masimo Pleth variability Index (PVI) was recently introduced as a safe, reliable, and noninvasive alternative to guide fluid management. The pulse oximeter plethysmographic waveform differs from the arterial pressure waveform by measuring volume rather than pressure changes in both arteries and veins. The ¿pleth variability index¿ (PVI) is an automated measure of the dynamic change in the perfusion index (PI) that occurs during a respiratory cycle. The perfusion index (PI) is the ratio of nonpulsatile to pulsatile blood flow through the peripheral capillary bed. PVI has been shown to help clinicians predict fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery and in the ICU. PVI has been shown to help clinicians improve fluid management and decrease lactate levels compared to standard care. PVI demonstrated high accuracy in discriminating fluid responders from non-responders¿providing a unique opportunity to better manage a patient¿s fluid volume to optimize cardiac performance and organ perfusion. PVI >14% prior to volume expansion is predictive that a patient will respond to fluid administration (81% sensitivity). PVI <14% prior to volume expansion is predictive that a patient will not respond to fluid administration (100% specificity). It seems to provide a simple alternative for accurate, noninvasive, and continuous preload monitoring.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Major Abdominal Surgeries,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/11/2014
Actual trial start date 01/12/2014
Anticipated date of last follow up 31/10/2015
Actual Last follow-up date 05/11/2015
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
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
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TED throughout the whole study throughout the whole study A CardioQ-ODM probe (Deltex Medical, Chichester, UK) will be inserted orally into the esophagus and the position will be adjusted to attain the maximal SV( approximately 35¿40 cm from the teeth). 60
Experimental Group MASIMO throughout the whole study throughout the whole study Masimo Radical-7 Pulse CO-Oximeter probes (Masimo Corporation, Irvine, CA) will be applied to the index finger of each patient 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Age: 25-60 years old. 2.Gender: Both male & female. 3.ASA I &II. 4.BMI: 18.5-24.9 Kg/m2 (Normal weight). 5.Major abdominal or pelvic surgery 1.Extremes of age. 2.The patient with increased risk of injury or bleeding, e.g.; esophageal or oropharyngeal malformations, strictures, varices, oesophagitis, recent oesophageal or upper airway surgery and long term corticosteroid therapy or severe bleeding. 3.Significant coagulopathy defined as (INR > 1.5 or PTT >1.5 times normal). 4.Use of anti platelets and anticoagulants. 5.Patients with uncontrolled diabetes, hypertension or cardiac condition. 25 Year(s) 60 Year(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 01/03/2011 Theodor Bilharz Research Institute
Ethics Committee Address
Street address City Postal code Country
Kornish El-Nile, Warrak El-Hadar Giza 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Doppler derived measurements :FTc, SVV 1.T1: Five minutes post-induction (baseline parameters) 2.T2: Ten minutes after volume expansion (500 ml colloid solution) 3.T3: If the SV decreased by 10%, (guided by Doppler)then 250 ml colloid is given , . 4.T4: Ten minutes after a 250-mL bolus infusion of colloid solution.
Primary Outcome Masimo Pleth variability Index (PVI and PI). 1.T1: Five minutes post-induction (baseline parameters) 2.T2: Ten minutes after volume expansion (500 ml colloid solution) 3.T3: If the SV decreased by 10%, (guided by Doppler)then 250 ml colloid is given , . 4.T4: Ten minutes after a 250-mL bolus infusion of colloid solution.
Secondary Outcome Heart Rate 1.T1: Five minutes post-induction (baseline parameters) 2.T2: Ten minutes after volume expansion (500 ml colloid solution) 3.T3: If the SV decreased by 10%, (guided by Doppler)then 250 ml colloid is given , . 4.T4: Ten minutes after a 250-mL bolus infusion of colloid solution.
Secondary Outcome Mean Arterial Blood Pressure 1.T1: Five minutes post-induction (baseline parameters) 2.T2: Ten minutes after volume expansion (500 ml colloid solution) 3.T3: If the SV decreased by 10%, (guided by Doppler)then 250 ml colloid is given , . 4.T4: Ten minutes after a 250-mL bolus infusion of colloid solution.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Theodor Bilharz Research Institute Kornish El-Nile- Warrak El-Hadar giza 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Theodor Bilharz Research Institiue Kornish El-Nile, Warrak El-HAdar Giza 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Theodor Bilharz Research Institute Kornish El-Nile, Warrak El-Hadar Giza 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed Essam 9 el-gehad st. Lebanon sq.-Mohandseen Giza 12345 Egypt
Mohamed Zeidan Ali Theodor Bilharz Research Institute Giza 12345 Egypt
Hossam Helmy elsabae Theodor Bilharz Research Institute Giza 12345 Egypt
Sohila Hussein Omar Theodor Bilharz Research Institute Giza 12345 Egypt
Mohamed Hafez El-Saied Hafez Kasr El-Ainy Medical School Cairo 11335 Egypt
Ali Mokhtar Kasr El-Ainy Medical School Cairo 11335 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Essam am_essam80@yahoo.com +201001562929 9 el-gehad st. Lebanon sq.-Mohandseen9 el-gehad st. Lebanon sq.-Mohandseen
City Postal code Country Position/Affiliation
Giza 12345 Egypt Theodor Bilharz Research Institute
Role Name Email Phone Street address
Public Enquiries Hossam El-Sabae Helmyh34@yahoo.com +201001592770 Theodor Bilharz Research Institute, Warrak El-Hadar
City Postal code Country Position/Affiliation
Giza 12345 Egypt Professor, Theodor Bilharz Research Institute
Role Name Email Phone Street address
Scientific Enquiries Mohamed Zeidan zeidanoma@hotmail.com +201111113115 Theodor Bilharz Research Institute, Warrak El-Hadar
City Postal code Country Position/Affiliation
Giza 12345 Egypt Professor, Theodor Bilharz Research Institute
REPORTING
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