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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202501544901723 Date of Registration: 17/01/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pressure Support Mode Versus Volume Support Mode for weaning mechanically ventilated patients.
Official scientific title Pressure Support Mode Versus Volume Support Mode for weaning mechanically ventilated patients.
Brief summary describing the background and objectives of the trial Weaning from mechanical ventilation is a gradual process aimed at transitioning patients to spontaneous breathing. Success in weaning is defined as maintaining sustained spontaneous breathing for more than 48 hours after extubation without the need for either invasive or non-invasive mechanical ventilation. Failure of weaning is indicated by the necessity for reintubation or the application of non-invasive ventilation (NIV) within 48 hours post-extubation. Various methods can be employed during the weaning process, including spontaneous modes such as low-level pressure support mode, volume support mode, or automatic tube compensation mode. However, there is no clear evidence indicating which mode is superior for weaning. In this randomized clinical trial, we will compare the success rates of weaning from mechanical ventilation using pressure support mode versus volume support mode as the primary outcome. Additionally, we will assess secondary outcomes including patient comfort, duration of successful weaning, the need for sedation, and ventilator-associated complications between the two modes.
Type of trial RCT
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 Treatment: Devices
Anticipated trial start date 25/08/2024
Actual trial start date 01/09/2024
Anticipated date of last follow up 15/02/2025
Actual Last follow-up date 01/03/2025
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 102
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group pressure support mode during process of simple weaning using pressure support mode and following a standardized weaning protocol (FiO2 and airway pressure will be adjusted providing that PaCO2 to be 35–45 mmHg, pH to be >7.32, VT to be 6–8 mL kg−1, saturation to be >92%, and PaO2 to be >60 mmHg). 51 Active-Treatment of Control Group
Experimental Group volume support mode process of simple weaning using volume support mode and following a standardized weaning protocol (FiO2 and airway pressure will be adjusted providing that PaCO2 to be 35–45 mmHg, pH to be >7.32, VT to be 6–8 mL kg−1, saturation to be >92%, and PaO2 to be >60 mmHg).(15) 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Adult patients, aged between 18 to 70 years. 2.Patient who are mechanically ventilated more than 48 hours , less than 10 days and meet all the following criteria for spontaneous breathing trial: 1.Pregnancy 2.BMI > 35 3.Thoracostomy or pneumothorax 4.Flail chest or rib fracture 5.Neuromuscular diseas 6.Diaphragmatic paralysis 7.Cerebrovascular stroke with bulbar symptoms Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 01/07/2024 public health and comunity medicine department menufia univercity
Ethics Committee Address
Street address City Postal code Country
Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine Shebeen elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess duraAssess duration for weaning in both groupstion for weaning in both groups during the process of simple weaning
Secondary Outcome Assess clinical data, arterial blood gas, vital signes, respiratory mechanics (tidal volume, respiratory rate, compliance) and patient comfort in both groups during the process of simple weaning
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospitals gamal abdelnaser street shebeen elkom Egypt
mahalla cardiology centre khaled ibn elwaleed mahalla Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 3 Al halawy pharmacy st. Qotour 31726 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor no sponsors no sponsors no sponsors Egypt no sponsors
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr abdelhakim amoramr201249@gmail.com 00201091610046 shebl street
City Postal code Country Position/Affiliation
Qotour 31726 Egypt icu resident
Role Name Email Phone Street address
Public Enquiries walaa samy walaasamy40@yahoo.com 00201000683038 gamal abdelnasir street
City Postal code Country Position/Affiliation
shebeen elkom Egypt lecturer of critical care medicine menofia univercity
Role Name Email Phone Street address
Scientific Enquiries hanady elfiky hanadymhmmd@gmail.com 00201068004428 ahmed oraby
City Postal code Country Position/Affiliation
shebeen elkom Egypt lecturer of critical care medicine menofia univercity
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 no
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 02/09/2024 i added a brief background about the trial this trial compares success rates, patient comfort, and duration of simple weaning from mechanical ventilation using pressure support mode versus volume support mode Weaning from mechanical ventilation is a gradual process aimed at transitioning patients to spontaneous breathing. Success in weaning is defined as maintaining sustained spontaneous breathing for more than 48 hours after extubation without the need for either invasive or non-invasive mechanical ventilation. Failure of weaning is indicated by the necessity for reintubation or the application of non-invasive ventilation (NIV) within 48 hours post-extubation. Various methods can be employed during the weaning process, including spontaneous modes such as low-level pressure support mode, volume support mode, or automatic tube compensation mode. However, there is no clear evidence indicating which mode is superior for weaning. In this randomized clinical trial, we will compare the success rates of weaning from mechanical ventilation using pressure support mode versus volume support mode as the primary outcome. Additionally, we will assess secondary outcomes including patient comfort, duration of successful weaning, the need for sedation, and ventilator-associated complications between the two modes.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 17/08/2024 Filing some papers at the university 01 Jun 2024 25 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 17/08/2024 No change 07 Jul 2024 01 Sep 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 17/08/2024 Filing some papers at the university 01 Nov 2024 15 Feb 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 17/08/2024 No change 01 Feb 2025 01 Mar 2025
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 17/08/2024 Organization 1.Adult patients, aged between 18 to 70 years. 2.Patient who are mechanically ventilated more than 48 hours , less than 10 days and meet all the following criteria for spontaneous breathing trial: 1.Adult patients, aged between 18 to 70 years. 2.Patient who are mechanically ventilated more than 48 hours , less than 10 days and meet all the following criteria for spontaneous breathing trial:
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 17/08/2024 Organization 1.Pregnancy 2.BMI > 35 3.Thoracostomy or pneumothorax 4.Flail chest or rib fracture 5.Neuromuscular disease 6.Diaphragmatic paralysis 7.Cerebrovascular stroke with bulbar symptoms 1.Pregnancy 2.BMI > 35 3.Thoracostomy or pneumothorax 4.Flail chest or rib fracture 5.Neuromuscular diseas 6.Diaphragmatic paralysis 7.Cerebrovascular stroke with bulbar symptoms
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/09/2024 correction of writing error regarding date of ethical approval TRUE, public health and comunity medicine department menufia univercity, Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine, Shebeen elkom, 32511, Egypt, , 25 Jun 2024, 0482222731, deanoffice@med.menofia.edu.eg, 31738_29839_4737.pdf TRUE, public health and comunity medicine department menufia univercity, Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine, Shebeen elkom, 32511, Egypt, , 01 Jul 2024, 0482222731, deanoffice@med.menofia.edu.eg, 31738_29839_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/10/2024 correction of writing error regarding date of ethical approval TRUE, public health and comunity medicine department menufia univercity, Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine, Shebeen elkom, 32511, Egypt, , 01 Jul 2024, 0482222731, deanoffice@med.menofia.edu.eg, 31738_29839_4737.pdf TRUE, public health and comunity medicine department menufia univercity, Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St - Faculty of Medicine, Shebeen elkom, 32511, Egypt, , 01 Jul 2024, 0482222731, deanoffice@med.menofia.edu.eg, 31738_29839_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 02/09/2024 Correction of IPD description study still in recruting individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Immediately following publication, No end date