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.: PACTR201807724785514 Date of Approval: 10/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Oxygen Reserve Index as an oxygen monitor in Whipple Surgical Procedure
Official scientific title Oxygen Reserve Index as a Perioperative Guide for Alveolar Recruitment Maneuver in Whipple Surgical Procedure
Brief summary describing the background and objectives of the trial A pancreaticoduodenectomy, Whipple procedure, is a lengthy major surgical operation.Optimal perioperative care is considered an important challenge for anethesists as most of the patients are older population and could suffer from medical illnes.Recruitment is a ventilator strategy which aims to re-expand any peripherally collapsed lung tissue, and maintain this re-expansion with an optimal positive end expiratory pressure (PEEP) to prevent subsequent de-recruitment. A new technology was recently developed to measure a parameter named oxygen reserve index (ORI) which uses a proprietary algorithm to estimate oxygen reserve using noninvasive hemoglobin sensors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ORI
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2018
Actual trial start date 01/08/2018
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date 01/08/2020
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Recruiting
Publication URL ORI as perioperative monitor
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ORI as oxygen monitor this probe applied to each patient allover the operation This group will be subjected to recruitment but not guided by ORI. The ORI readings will be recorded throughout the operative period, but the assessor doctor will be blinded to the ORI data 21 Placebo
Experimental Group ORI as oxygen monitor it is a probe applied to patienta allover the operation This group will be subjected to recruitment guided by ORI in order to keep PaO2 between 120-150 mmHg 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adults scheduled for elective Whipple’s operations. • ASA classification I-III • Patients with pre-existing significant pulmonary disease. • Cardiac co-morbidity. • Refusal to participate in the study. • Body-mass index higher than 40 kg/m2. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 01/07/2018 menufia universty
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebeen elkom 1234567 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Use of ORI as a guide for alveolar recruitment level (Positive End Expiratory Pressure, PEEP adjustments) mmHg and the titration of adequate fractional inspired oxygen. (FiO2) base line, After Anaesthesia Induction, During dissection, End surgery, 3 hours post-extubation
Secondary Outcome  Relation between ORI and arterial oxygen tension in blood (PaO2) mmHg  To investigate the beneficial role of ORI in preventing unintended hyperoxia  Comparing ORI to regular pulse oximetry oxygen saturation (%) as an early alarm for hypoxia particularly during induction of anesthesia and recovery in Post Anesthesia Care Unit (PACU). base line, After Anaesthesia Induction, During dissection, End surgery, 3 hours post-extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shebeen elkoom 1234567 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor natinal liver institute yassen abdelghafar shebaan elkoom 1234567 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amira Fathy yassen abdelghafar shebeen elkoom 1234567 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amira fathy n.elhoda7711@yahoo.com 00234578 yassen abd elghafar
City Postal code Country Position/Affiliation
shebeen el koom 1234567 Egypt assisstant lecturer
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 00201001345 yassen abd elghafar
City Postal code Country Position/Affiliation
shebeen el koom 1234567 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries amira fathy n.elhoda7711@yahoo.com 00234578 yassen abd elghafar
City Postal code Country Position/Affiliation
shebeen el koom 1234567 Egypt assisstant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information