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.: PACTR201909915486179 Date of Approval: 05/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early Bronchoscopy for Aspiration
Official scientific title The use of early bronchoscopy in mechanically ventilated patients with aspiration pneumonitis
Brief summary describing the background and objectives of the trial Aspiration induced lung injury accounts for a significant proportion of acute pulmonary dysfunction. Few studies were conducted to study the use of early bronchoscopy in mechanically ventilated patients with aspiration pneumonitis. The aim of this study is to assess the clinical impact of early bronchoscopy for removal of gastric fluid and solid particles in the first 24 hrs of MV on the progression of aspiration, MV days, ICU stay, development of pneumonia and ICU mortality
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: Other
Anticipated trial start date 01/03/2019
Actual trial start date 09/04/2019
Anticipated date of last follow up 31/10/2019
Actual Last follow-up date 26/09/2019
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 76
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early Bronchoscopy once in the first 24 hrs once bronchoscopy in the first 24 hrs after admission for suction of secretions, airway clearance and sampling bronchoalveolar lavage in addition tostandard medical care as antibiotics if needed 35
Control Group standard care duration of ICU stay standard medical care eg minibal sampling , antibiotics if needed 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18 years and more. Patients presented with acute aspiration evident by gastric contents in the oropharynx leading to some or all of the following; Fever, Dyspnea, Wheezes, Crackles and Cough in a patient with risk factors for aspiration Patients requiring intubation and mechanical ventilation Patients with signs and symptoms suggestive of pneumonia prior to the event of aspiration Patients with Chronic pulmonary diseases 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 999 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 20/07/2017 Ethics Committee Faculty of Medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
Shamplion street Alexandria 21211 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development of Aspiration pneumonia 3 days after aspiration event
Secondary Outcome Mortality Discharge from ICU or death
Secondary Outcome Days of Mechanical ventilation weaning from mechanical ventialtion or death
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main University Hospital Shamplioon street Alexandria 21211 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ibrahim ElBitash street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Alexandria University shamplion street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Ahmed Mustafa Elmenshawy Shamplion street Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ibrahim amibrahim00@gmail.com 00201111710525 Albitash street
City Postal code Country Position/Affiliation
Alexandria Egypt Assisstant lecturer Faculty of medicine alexandria university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elmenshawy ahmedmenshawy@hotmail.com 00201110778295 Alkhartoum square
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer Faculty of medicine alexandria university
Role Name Email Phone Street address
Public Enquiries Ahmed Ibrahim amibrahim00@gmail.com 00201111710525 Albitash street
City Postal code Country Position/Affiliation
Alexandria Egypt Assisstant lecturer Faculty of medicine alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary of data collected from participants Study Protocol available starting from march 2020 request via email
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