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.: PACTR202108881017604 Date of Approval: 25/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title “Weaning modes” of mechanical ventilation in patients with “difficult weaning”
Official scientific title A comparative study among three “weaning modes” of mechanical ventilation in patients with “difficult weaning”
Brief summary describing the background and objectives of the trial The aim of this study is to compare between 3 different modes of mechanical ventilation; Pressure Support Ventilation (PSV) versus Volume Support Ventilation (VSV) versus Mandatory Minute Ventilation (MMV) as weaning modes in “difficult weaning” patients. The primary outcome will be “Rate of successful weaning”. Secondary outcomes will be; Total weaning Time (TWT), total duration of mechanical ventilation (TMVT), need for non-invasive ventilation after extubation, and need for sedation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/06/2021
Actual trial start date
Anticipated date of last follow up 01/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants)
Recruitment status Not yet 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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Pressure support Ventilation mode till weaning of mechanical ventilation In the PSV group (Group 1), Fraction of inspired oxygen (FiO2) and positive end expiratory pressure (PEEP) will be adjusted to provide oxygen saturation > 92%, and partial pressure of oxygen (PaO2) > 60 mmHg. Pressure support (PS) will be adjusted to provide Tidal volume (VT) of 6-8 mL/ kg, partial pressure of carbon dioxide (PaCO2) to be 35-45 mmHg or the patient`s baseline value in chronic retainer patients and pH > 7.32. Level of pressure support will be gradually decreased by 1-4 cmH2O /day according to patient condition, till reach level of 8 cmH2O. In case of patient fatigue, level of pressure support will be temporary increased, and if patient is still experiencing high work of breathing, the mode will be shifted to VC-CMV for few hours then PSV will be restarted again. 35 Active-Treatment of Control Group
Experimental Group Volume support Ventilation mode till ICU discharge In the VSV group (Group 2), setup parameters will include VT of 6-8 mL/kg targeting to maintain PaCO2 at 35-45 mmHg or the patient`s baseline value in chronic retainer patients and pH >7.32. FiO2 and PEEP will be adjusted to maintain saturation > 92%, and PaO2 > 60 mmHg. High pressure alarm will be set at 30 mmHg. In case of patient fatigue or patient is experiencing high work of breathing, the mode will be shifted to VC-CMV for few hours then VSV will be restarted again. 35
Experimental Group Mandatory Minute Ventilation mode Till ICU discharge In the MMV group (Group 3), setup parameters will include VT of 6-8 mL/kg, RR 10-15/minute, providing that pH to be >7.32 and PaCO2 to be 35-45 mmHg or the patient`s baseline value in chronic retainer patients. FiO2 and PEEP will be adjusted to maintain saturation to be > 92%, and PaO2 to be > 60 mmHg. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
difficult weaning” of mechanical ventilation (defined as failure of first Spontaneous Breathing Trial (SBT) or reintubation within 48 hours after the first extubation attempt in patients who fulfill readiness criteria for weaning) - Age less than 18 or more than 75 years old - Body mass index more than 35 kilogram/ meter 2 - Respiratory arrest or apnea - Chest trauma - Acute respiratory distress syndrome - Brain stem infarction, hemorrhage or death - Cervical spinal cord injury - High risk of aspiration e.g.; cerebral stroke with bulbar manifestations - Acute or chronic myopathy or polyneuropathy affecting respiratory muscles - Cardiomyopathy (Ejection fraction less than 45%) - Severe shock state on high doses of vasopressors - Post Major operations - Burst abdomen - Lack of informed consent Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 14/12/2019 Faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin el-kom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rate of successful weaning of mechanical ventilation ICU discharge
Secondary Outcome total ‘weaning’ time (TWT). ICU discharge
Secondary Outcome total duration of mechanical ventilation (TMVT) ICU discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Hospital Yassin Abdelghafar Shibin Elkom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin elkom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelrhman Ali Aboshady Sadat Seconary School street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrhman Aboshady abdelrhman.aboshady@med.menofia.edu.eg 2201008757406 Sadat Secondary Shcool street
City Postal code Country Position/Affiliation
shibin elkom 002048 Egypt Assistant Lecturer
Role Name Email Phone Street address
Principal Investigator Nadia Bahgat dr_nmbahgat@yahoo.com 00201009558238 Mohammed Husseini street
City Postal code Country Position/Affiliation
Shibin Elkom Egypt Lecturer of anesthesia and intensive Care
Role Name Email Phone Street address
Public Enquiries Yaser Fathy criticalcare65@gmail.com 00201099004664 25 Yasin Abd-Elghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Hatem Attalla Hatattalla@hotmail.com 00201001445568 Al Bahari street
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of anesthesia and intensive Care
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) will be shared with researchers who provide a methodologically sound proposal. Proposal should be directed to (abdelrhman.aboshady@med.menofia.edu.eg) To gain access, data requestors will need to sign a data access agreement. Data will be available Immediately following publication, No end date. Study Protocol Data will be available Immediately following publication, No end date. Proposal should be directed to (abdelrhman.aboshady@med.menofia.edu.eg) To gain access, data requestors will need to sign a data access agreement.
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