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.: PACTR202111766112898 Date of Approval: 29/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Peripheral venous line placement: Procedural Simulation vs. Standard Patient (Randomized trial)
Official scientific title Peripheral venous line placement: Procedural Simulation vs. Standard Patient (Randomized trial)
Brief summary describing the background and objectives of the trial The Know-how must necessarily involve medical simulation in order to improve efficiency and ensure patient safety (level 1 evidence-grade A recommendation). The placement of a peripheral venous line (PVL) is a procedure that all healthcare providers must be able to perform because it is the first procedure performed for any patient admitted to the hospital. Procedural simulation on mannequin arms is an appropriate way to learn how to place a PVL. Medical simulation puts the learner in an environment almost similar to a hospital environment. The standardized patient is a medical simulation technique that replicates a hospital environment. Standardized patient (SP), considered a high-fidelity simulation compared to low-fidelity procedural simulation, is a proven technique. The objective of this study is to compare two simulation techniques in learning how to set up a PVL (low-fidelity simulation: the mannequin arm versus a high-fidelity simulator: the standardized patient [SP]) in terms of efficiency according to the French hospital hygiene society.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Patient Simulation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2022
Actual trial start date
Anticipated date of last follow up 31/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Procedural Simulation equal to or less than 15 minutes Patient Simulation (PS) this is a low fidelity simulation represented by male infusion arms (Laerdal® male multi-venous training arm) glued to a full body mannequin (Laerdal® Rescuci). The learner will perform the gesture, while an evaluator fills in an assessment grid created beforehand. The overall time dedicated to the scenario must not exceed fifteen minutes, beyond which the facilitator must intervene to help the learner complete the gesture (the intervention of the facilitator will be considered as a failure in relation to outcome measure). 160 Historical
Experimental Group Standardized patient equal or less than 15 minutes it is a procedure where a person, who has been trained to simulate a patient undergoing PVL placement. This person, to whom a Laerdal® male multi-venous training arm is attached, must react as a patient in pain for whom a peripheral venous line is to be placed for care. This Standardized patient (SP) should be trained to act in an appropriate environment, the scenario must reproduce the clinical situation, the whole meeting the educational objectives according to the job profile. 160
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
2nd year nursing students from the Honoris United Universities group 1st and 3rd year Honoris students, students from other equivalent institutions Adult: 19 Year-44 Year 19 Year(s) 44 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 08/10/2021 Local ethics committee of Charles Nicolle Hospital
Ethics Committee Address
Street address City Postal code Country
9 avril 1938 Tunis 1006 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome successful catheterization after the second attempt. A successful attempt corresponds to the complete introduction of the catheter with the return of blood into the chamber of the chuck and the presence of blood return in the siphoning test. A failed attempt is defined as complete or incomplete catheter insertion with no blood return to the chuck control chamber or no blood return in the siphoning test 15 minutes
Secondary Outcome Time to successful catheterization 15 minutes
Secondary Outcome Number of attempts. 15 minutes
Secondary Outcome Adherence to asepsis (learner touches catheter, disinfected site or puncture site) 15 minutes
Secondary Outcome Safety compliance (learner does not immediately dispose of the chuck in the sharps container) 15 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Honoris Medical Simulation Center Corner of Ave Khereddine Pacha and Cote d Ivoire street Tunis 1002 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Honoris United Universities rue Lac Neuchatel - Lac 1 - Les berges du Lac Tunis 1053 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Honoris United Universities rue Lac Neuchatel - Lac 1 - Les berges du Lac Tunis 1053 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Amara bamara@tn.honoris.net +21627246716 Corner of khereddine pacha and cote d ivoire street
City Postal code Country Position/Affiliation
TUNIS 1002 Tunisia simulation operation specialist
Role Name Email Phone Street address
Public Enquiries Mouna Ben Rhouma mouna.benrhouma@universitecentrale.tn +21627246758 Corner of khereddine pacha and cote d ivoire street
City Postal code Country Position/Affiliation
TUNIS 1002 Tunisia Simulation educator
Role Name Email Phone Street address
Principal Investigator Mamoun Ben Cheikh benche2005@gmail.com +21698422929 Corner of Khereddine Pacha and Cote d Ivoire street
City Postal code Country Position/Affiliation
Tunis 1002 Tunisia Simulation facilitator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Will individual participant data be available (including data dictionaries)? yes 2. What data in particular will be shared? Not applicable 3. What other documents will be available? Not applicable 4. When will data be available (start and end date)? Not applicable 5. With who? Not applicable 6. For what types of analyses? Not applicable 7. By what mechanism will date be made available After completion of this study, results will be published in an original article as well as on this clinical trial registry in PACTR Study Protocol SIX months after study completion the PI Prof. Chadli Dziri will be the one overviewing the data analysis, results sharing, article publication and serving as a contact author
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