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.: PACTR202408823933769 Date of Approval: 08/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of diaphragmatic ultrasound as a predictor of successful weaning from mechanical ventilation
Official scientific title Effectiveness of diaphragmatic ultrasound as a predictor of successful weaning from mechanical ventilation
Brief summary describing the background and objectives of the trial Ultrasound evaluation of the diaphragm gains popularity in the ICU as a simple, non-invasive bedside method to assess the functional status of the diaphragm. Ultrasonography (US) allows the qualitative and quantitative assessment of diaphragmatic function which are helpful clinically in diagnosing diaphragmatic weakness and in examining respiratory workload in patients in the ICU.We aim to use the diaphragmatic based rapid shallow breathing indices as a predictive tool for weaning success during spontaneous breathing trial in mechanically ventilated patients. Primary outcome: To determine the predictive value of diaphragmatic rapid shallow breathing indices in successful weaning from the ventilator. Secondary outcome: Correlation between the diaphragmatic indices and days of invasive mechanical ventilation, length of stay in the ICU and ICU mortality.  
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/10/2023
Actual trial start date 01/11/2023
Anticipated date of last follow up 14/07/2024
Actual Last follow-up date 30/08/2024
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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 Non-randomised Numbered containers Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound diaphragmatic rapid shallow breathing indices Conventional rapid shallow breathing index and ultrasound diaphragmatic rapid shallow breathing indices will be recorded immediately at the beginning of SBT and at the end of the SBT A spontaneous breathing trial will be done using a pressure support ventilation , with a pressure support of 10 cmH2O and PEEP of 5 cmH2O for 30 min. The intensivist in duty (who will be blinded to the ultrasonography parameters) will decide whether to extubate or wean from the ventilation after collecting ultrasound diaphragmatic indices initially and at the end of the weaning trial. Patients with successful weaning will be included in the success group, and the others who fail will be included in the failure group. Conventional rapid shallow breathing index will be calculated by dividing RR by tidal volume (RR/ VT) twice for each patient, at the beginning of SBT and after the SBT. Diaphragm ultrasound: Diaphragmatic measurements will be performed in the ICU by a trained ICU doctor who is not involved in patient care. We will use the bedside ultrasound machine with lung or abdominal preset, A curvilinear probe (5 MHz) will be used with Two-dimensional mode to do the exam. Diaphragm movement will be measured over one of the lower intercostal spaces in the right mid axillary line for the right diaphragm assessment. The right hemi-diaphragm will be imaged at the zone of apposition of the diaphragm and rib cage on the mid-axillary line between the 8th and 10th intercostal spaces. Diaphragmatic excursion (DE) will be measured on the vertical axis by tracing the diaphragmatic amplitude from the baseline to the point of maximum Hight of inspiration. Diaphragm thickness (DT) will be measured at both end-inspiration and end-expiration and the DT difference (DTD) will be calculated. Diaphragmatic based rapid shallow breathing indices will be calculated by replacing tidal volume in rapid shallow breathing index by DTF to calculate diaphragmatic thickness fraction rapid shallow breathing index and DE to calculate diaphragmatic excursion rapid shallow breathing index. 50
Control Group No NO No No 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1- Adult patients, aged between 18 to 65 years. 2- Patient who are mechanically ventilated more than 48 hours and meet all the following criteria for spontaneous breathing trial: • Resolution or improvement of the disease leading to MV, • adequate oxygenation indicated by arterial oxygen saturation (SaO2)>90% with inspired oxygen fraction (FiO2) ≤0.5, or arterial oxygen partial pressure to inspired oxygen fraction (PaO2/FiO2)≥150 mmHg, both with positive end-expiratory pressure (PEEP)≤8 cmH2O, • respiratory rate≤30 breaths/min, • intact cough reflex • hemodynamic stability in low dose or absence of vasopressors. Exclusion criteria: 1- Pregnancy 2- Thoracostomy or pneumothorax 3- Flail chest or rib fracture 4- Neuromuscular disease 5- Diaphragmatic paralysis 6- Cerebrovascular stroke with bulbar symptoms 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 03/09/2023 research ethical committee institutional review board at menoufia university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Yassin abdelaghfar street Shebeen Elkoom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome: To determine the predictive value of diaphragmatic rapid shallow breathing indices in successful weaning from the ventilator. two time points :initial at beginning of spontaneous breathing trial and the second one after end of spontaneous breathing trials
Secondary Outcome Secondary outcome: Correlation between the diaphragmatic indices and days of invasive mechanical ventilation, length of stay in the ICU and ICU mortality. once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
intensive care units at Menoufia University Hospitals Shebeen Elkoom , Menoufia Shebeen Elkoom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self Funded Shebeen Elkoom Shebeen Elkoom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor no Shebeen Elkoom Menoufia Shebeen Elkoom 32511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ramadan abaghasgho34@gmail.com 00201063541661 Shebeen Elkoom
City Postal code Country Position/Affiliation
Shebeen Elkoom 32511 Egypt M.B. B.CH
Role Name Email Phone Street address
Scientific Enquiries Hanady Elfeky hanadymhmmd@gmail.com 00201068004428 Shebeen Elkoom
City Postal code Country Position/Affiliation
Shebeen Elkoom 32511 Egypt Lecturer of critical care medicine Menoufia university
Role Name Email Phone Street address
Public Enquiries Noha Afify nohaafify2014@gmail.com 00201069113014 Menoufia
City Postal code Country Position/Affiliation
Sheeben Elkoom 32511 Egypt Assistant professor of Anesthesiology Intensive Care and Pain Management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Immediately following publication, No end date Study Protocol one year unavailable
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