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.: PACTR202405504971616 Date of Approval: 02/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Implementing Carotid Massage versus Ice Bag Maneuver on Clinical Outcomes for Children with Supraventricular Tachycardia
Official scientific title Effect of Implementing Carotid Massage versus Ice Bag Maneuver on Clinical Outcomes for Children with Supraventricular Tachycardia
Brief summary describing the background and objectives of the trial Supraventricular tachycardia (SVT) is an emergency condition in children as it may lead to serious complications such as hemodynamic compromise resulting in syncope, shock, or even congestive heart failure (CHF) and death. Some reviews stated that congestive heart failure may develop in 50% of SVT cases due to high children’s heart rates that reach 220-280 beats/minute (Kafalı & Ergül, 2022). Therefore, the importance of emergent management of such cases, that can be managed by non-pharmacological vagal maneuvers which are considered safe and effective in terminating SVT in up to 72% of cases (Ceylan et al., 2019). So, the aim of the study is to evaluate the effect of implementing carotid massage versus ice bag maneuver on clinical outcomes for children with supraventricular tachycardia.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2024
Actual trial start date 01/04/2024
Anticipated date of last follow up 01/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group carotid massage once 10 seconds -Provide a calm and quiet environment. -Put the child on supine position with the neck in an extended position, the head turned away from the side being massaged. - Only one side should be massaged at a time. - Pressure is applied underneath the angle of the jaw (over carotid sinus) in a gentle circular motion for about 10 seconds. 30
Experimental Group Ice bag maneuver once 15 seconds - Provide a calm and quiet environment. - Put the child on supine position. - Place an ice bag on the face (covering most of child's face as possible) for about 15 seconds. 30
Control Group No control group because this study is a comparison between two interventional groups No control group because this study is a comparison between two interventional groups No control group because this study is a comparison between two interventional groups No control group because this study is a comparison between two interventional groups 0 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Children with stable supraventricular tachycardia. - Age ranged from 1 to 12 years. - Both sexes. - Children with unstable Supraventricular tachycardia. - Exclusion criteria for carotid massage: - Carotid bruit (stenosis). - Cerebral vascular accident in the last three months. - Ventricular tachycardia, ventricular fibrillation, or myocardial infarction in the past three month. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 12 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 20/02/2024 Scientific Research Ethics Committee of faculty of nursing of Tanta university
Ethics Committee Address
Street address City Postal code Country
Al-Geish Street - Tanta - Gharbia Governorate Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Heart rate, ECG rhythm, respiration, blood pressure and oxygen saturation. immediately before, immediately after the intervention and 15 minutes later
Secondary Outcome Supraventricular tachycardia associated manifestation including dyspnea and nausea. immediately before, immediately after the intervention and 15 minutes later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric medical department of Tanta University Main Hospital Al-Geish Street - Tanta - Gharbia Governorate Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amany Shwitah Almror street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of nursing Algiesh street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Shwitah amany.khaled.shwitah@gmail.com 00201097419456 Almror street
City Postal code Country Position/Affiliation
Tanta Egypt Demonstrator of pediatric nursing
Role Name Email Phone Street address
Scientific Enquiries Rahma Soliman rahma.youssif@nursing.tanta.edu.eg 00201020515023 Mohamed Fared street
City Postal code Country Position/Affiliation
Alexandria Egypt professor of pediatric nursing
Role Name Email Phone Street address
Public Enquiries Samar Eldesoky samar_eldesoky@nursing.tanta.edu.eg 00201553238428 Feshar street
City Postal code Country Position/Affiliation
Elmahala Alkobra Egypt lecturer of pediatric nursing
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results will be shared in a word document format after the completion of the study at the site: https://data.mendeley.com/ Study Protocol within 12 months of the end of the study controlled access after approval of the supervisors
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