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.: PACTR202405716762553 Date of Approval: 13/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Thoracic Ultrasonography in Perioperative Care of Elective Cardiothoracic Surgery Patients
Official scientific title Role of Thoracic Ultrasonography in Perioperative Care of Elective Cardiothoracic Surgery Patients
Brief summary describing the background and objectives of the trial Thoracic ultrasonography (lung and pleural) can diagnose different chest diseases like pneumothorax, pleural effusion, pulmonary edema, pulmonary, pneumonia. It is easy to use, rapid and reliable. Postoperative pulmonary complications are among the most frequent problems in perioperative care. lung ultrasound can be used to detect postoperative pulmonary complications (respiratory infection, respiratory failure, atelectasis, pulmonary oedema, consolidation, pneumothorax, and pleural effusion) at an earlier timepoint than chest X-ray following cardiothoracic surgery enhancing bedside decision making. In addition, lung ultrasound can be used to evaluate the efficacy of therapies initiated for postoperative pulmonary complications. Thoracic ultrasound can be also used for ultrasonography guided intervention for chest diseases. The aim of this study is to assess the role of thoracic ultrasonography in postoperative care of elective cardiothoracic surgery patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2024
Actual trial start date 01/04/2024
Anticipated date of last follow up 01/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cardiothoracic Ultrasound N/A On admission, Day 2 and Day 3 postoperative Thoracic ultrasound (Lung and Pleura) will be performed using sonoscope E1 exp ultrasound machine with a 2-5 MHz convex probe for examination of the pleural effusion, visceral pleura, and lung parenchyma, whereas the parietal pleura and thoracic wall were examined with the use of a linear 5-10 MHz probe. No patient preparation is required. 150
Control Group Chest X Ray N/A On admission, Day 2 and Day 3 postoperative A chest radiography in the antero-posterior direction will be performed. Other direction may be added as postero-anterior and lateral decubitus positions. No patient preparation is required. 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- All patients scheduled for Cardiothoracic surgery on an elective basis. - Patients scheduled for cardiac surgery (isolated coronary artery bypass graft [CABG], isolated heart valve surgery [i.e., aortic, mitral, tricuspid, or pulmonic valve replacement or repair], heart surgery for atrial myxoma, aortic surgery, or combined surgery. - Patients scheduled for thoracic surgery (diaphragmatic hernia repair, diaphragmatic eventration repair decortication, pneumonectomy, lobectomy, segmentectomy, thymectomy, VATs sympathectomy). - Patients scheduled for chest ultrasound guided intervention. - Refuse to participate. - Can't be assessed by thoracic ultrasonography due to technical issues. - Patients with subcutaneous emphysema. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 26/02/2024 Kafr Elsheikh University Scientific Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Kafr Elshikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Atelectasis On admission, Day 2 or Day 3 postoperative
Primary Outcome Pulmonary edema On admission, Day 2 or Day 3 postoperative
Primary Outcome Pneumothorax On admission, Day 2 or Day 3 postoperative
Primary Outcome Pleural effusion On admission, Day 2 or Day 3 postoperative
Secondary Outcome Consolidation On admission, Day 2 or Day 3 postoperative
Secondary Outcome Diaphragmatic paralysis On admission, Day 2 or Day 3 postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Cardiothoracic Surgery Faculty of Medicine Kafrelsheikh University ElGish street Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aya Mohammed Tolba Saleh Mosque street Siriwa Al-Kubra Bella 33634 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Kafr Elshikh University El Gash street Medical Campus Kafrelsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Moustafa Abdelaal Ibrahim Moghazy street Kafrelsheikh 33516 Egypt
Wael Mohamed Elfeky 1 street 108, Taksim 2 Kafrelsheikh 33518 Egypt
Aya Mohammed Tolba Saleh Mosque street, Siriwa Al-Kubra, Bella 33634 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Abdelaal mohammed_abdelaal@med.kfs.edu.eg 00201001422577 Ibrahim Moghazy street
City Postal code Country Position/Affiliation
Kafrelsheikh 33516 Egypt Professor of Cardiothoracic Surgery Kafr Elsheikh University Egypt
Role Name Email Phone Street address
Scientific Enquiries Wael Elfeky Waelfeky@yahoo.com 00201004332200 1 street 108, Taksim 2
City Postal code Country Position/Affiliation
Kafrelsheikh 33518 Egypt Professor of Cardiothoracic Surgery Kafr Elsheikh University Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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