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.: PACTR202011718030425 Date of Approval: 02/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Echo and lung ultrasound for weaning
Official scientific title Combined use of Lung and heart ultrasound: possible predictors of weaning failure of ventilated patients
Brief summary describing the background and objectives of the trial This study aims to identify if combined lung ultrasound and TTE can predict weaning failure to highlight the important role of systolic or diastolic dysfunction in the weaning process and what early management could be initiated to improve the outcome. Study outcomes: Primary outcome: weaning and/ or extubation success rate and associated lung ultrasound and TTE findings. Secondary outcome: determination of the major contributors in the weaning process; lung aeration loss or high LV filling pressure or both. Any patient fulfills standard criteria of extubation and decided to enter SBT by the treating intensivist, will examined by LUS & TTE. The SBT will be performed through pressure support mode (PS) of mechanical ventilation with PEEP ≤ 5 cmH2O, pressure support of ≤ 7 cmH2O, FIO2<0.5, P/F ratio>200 and RR< 30 b/m. LUS examination and mitral Doppler study will be performed 30min prior to SBT, 30min after SBT and at the end of the trial. The decision to stop SBT or to extubate was made by the physician in charge independently of the investigators
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/05/2020
Actual trial start date
Anticipated date of last follow up 15/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 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 Echo and lung ultrasound 30 min before the trial, 30 min after the trial and at the end of the trial Any patient fulfills standard criteria of extubation and decided to enter SBT by the treating intensivist, will examined by LUS & TTE. The SBT will be performed through pressure support mode (PS) of mechanical ventilation with PEEP ≤ 5 cmH2O, pressure support of ≤ 7 cmH2O, FIO2<0.5, P/F ratio>200 and RR< 30 b/m. LUS examination and mitral Doppler study will be performed 30min prior to SBT, 30min after SBT and at the end of the trial. The decision to stop SBT or to extubate was made by the physician in charge independently of the investigators. SBT failure considered in: patient exhaustion, anxiety, diaphoresis, RR>35 b/m, paradoxical breathing and use of accessory respiratory muscles, unstable hemodynamics and oxygen saturation <90%. 50
Control Group No control group No control group No control group 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 20-70 years both sexes mechanically ventilated for 24 hours or more, have underlying disease considered reversed and eligible for extubation by the treating intensivist. (GCS above 8, adequate oxygenation and ventilation, ability to protect his own airway with good cough reflex.) Age < 20 & > 70 years old tracheostomy, active neuromuscular disease, pregnancy, ejection fraction < 50% at enrolment, significant COPD history, previous SBT failure, pneumothorax pleural effusion Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 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 21/04/2020 Instutional research board Mansoura Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 El gomhoria st, dakahlia, governorate Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome weaning and/ or extubation success rate and associated lung ultrasound and TTE findings. 30min prior to spontaneous breathing trial, 30min after the trial and at the end of the trial
Secondary Outcome the major contributors in the weaning process; lung aeration loss or high LV filling pressure or both. 30min prior to Spontaneous trial, 30min after the trial and at the end of the trial.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospitals Elgomhoria Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Mohammed Hamdy Salem Elnemr 7 montaser st, elgalaa Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Mohammed Hamdy Salem Elnemr 7 montaser st., elgalaa, Mansoura Mansoura 35511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mahmoud mohammed Alseoudy 6 montaser st, elgalaa Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Elnemr Egytigerrr_2020@yahoo.com +201004239394 7 montaser st, elgalaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Mansoura University
Role Name Email Phone Street address
Public Enquiries Ibrahim Elnemr Egytigerrr_2020@yahoo.com +201004239394 7 montaser st, elgalaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Elnemr Egytigerrr_2020@yahoo.com +201004239394 7 montaser st, elgalaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will make the IPD available on requist with keeping the individual identities, well-being, and safety. Study Protocol 2 years We will make the IPD available on requist with keeping the individual identities, well-being, and safety.
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