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.: PACTR202108547774603 Date of Approval: 02/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title INTRAOPERATIVE HEMODYNAMIC OPTIMIZATION BY USING PULSE PRESSURE VARIATIONS
Official scientific title Lung Recruitment Maneuver and Tidal Volume Challenge Improves the Prediction of Fluid Responsiveness Using Pulse Pressure Variation
Brief summary describing the background and objectives of the trial we want to explore a strategy of intraoperative hemodynamic optimization by pulse pressure variations (∆PP). we want to determine wether the tidal volume challenge is able to improve the relevance of ∆PP. it possible to respect the protective ventilation by varying the tidal volume? Furthermore, is it possible to use the hemodynamic changes induced by alveolar recruitment to predict the fuid responsiveness.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2020
Actual trial start date 01/03/2020
Anticipated date of last follow up 04/02/2021
Actual Last follow-up date 30/04/2021
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 79
Recruitment status Active, not 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group hemodynamic point before each fluid challenge during the entire operation The hemodynamic monitoring is performed by esophageal Doppler. A positive response is considered when the stroke volume exceedes 10% of its initial value. Before the fluid challenge, we carried out a series of measurements (∆PP) on different tidal volumes (6 ml, 8 ml and 10 ml) before, after and during alveolar recruitment 36 Active-Treatment of Control Group
Experimental Group hemodynamic point after anaesthetic induction throughout the whole operation The hemodynamic monitoring is performed by esophageal Doppler. A positive response is considered when the stroke volume exceedes 10% of its initial value. Before the fluid challenge, we carried out a series of measurements (∆PP) on different tidal volumes (6 ml, 8 ml and 10 ml) before, after and during alveolar recruitment. 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients eligible for intraoperative hemodynamic monitoring who do not have studs limiting the use of pulse pressure variations (∆PP). intraoperative development of hemodynamic intability or cardiac arrhythmia 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 11/02/2019 local protection committee
Ethics Committee Address
Street address City Postal code Country
Mont Fleury-1008 Tunis TUNIS 1008 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome determine the best Tidal Volume for predicting fluid responsiveness. after the anesthetic induction
Primary Outcome the ability of pulse pressure variations associated with tidal volume challenge and alveolar recruitment to predict fluid responsiveness. after the anesthetic induction
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Military Hospital of Tunis Mont Fleury-1008 Tunis TUNIS 1008 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Miliary Hospital of Instruction of Tunis Monfleury Tunis 1008 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MILITARY HOSPITAL OF TUNIS Mont Fleury-1008 Tunis TUNIS 1008 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Romdhani Chihebeddine Montfleury Tunis 1008 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali TRITAR tritarali@gmail.com 0021655013013 4 street ammar ibn yasser 2091 menzah 6 ariana
City Postal code Country Position/Affiliation
ARIANA 2091 Tunisia AUTHOR
Role Name Email Phone Street address
Scientific Enquiries Chihebeddine ROMDHANI chihebeddine.romdhani@fmt.utm.tn 0021692296965 4 STREET AMMAR IBN YASSER MENZAH 6 ARIANA
City Postal code Country Position/Affiliation
ARIANA 2091 Tunisia AUTHOR
Role Name Email Phone Street address
Public Enquiries IMEN NAAS naasimen@hotmail.fr 0021626622590 4 STREET AMMAR IBN YASSER MENZAH 6 ARIANA
City Postal code Country Position/Affiliation
ARIANA 2091 Tunisia AUTHOR
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