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.: PACTR202401788224049 Date of Approval: 22/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title high flow nasal oxygen versus non invasive ventilation for the prevention of post-extubation failure
Official scientific title high flow nasal oxygen versus non invasive ventilation for the prevention of post-extubation failure
Brief summary describing the background and objectives of the trial exploring efficacy of using high flow nasal oxygen versus using non invasive ventilation to prevent post extubation respiratory failure in patients mechanically ventilated for acute type two respiratory failure with risk factors for post extubation failure Niv is the most common device used to prevent post extubation failure, but it has some limitaions as intolerance, nasal ulceration and leaks. HFNO can produce flow dependent CO2 removal and can generate positive pressure equivalent to PEEP up to about 7 cmH2O, so it can reduce tachypnea and hypercapnia, while providing heated and humidified O2 which increase patient comfort and tolerance
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 Treatment: Devices
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 30/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 67
Actual target sample size (number of participants)
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 Non-randomised 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 high flow nasal oxygen at least 24 hours high flow nasal oxygen through nasal cannula 34
Control Group non invasive ventilation at least 24 hour non invasive ventilation 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients mechanically ventilated for acute type 2 respiratory failure with risk factors for post extubation failure patients above 18 years of age patients with no risk factor for post extubation failure Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 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 12/10/2022 research ethics committee faculty of medicine Cairo university
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Manial Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of efficacy of high flow nasal oxygen versus non invasive ventilation in prevention of post extubation failure one, 6, 12, 24 hours
Secondary Outcome assess predictors of outcome of high flow oxygen in preventing post extubation failure one,6,12,24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
chest department faculty of medicine Cairo university Kasr Alainy Mnial Cair0 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Kasr Alainy Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine Cairo university Kasr Alainy Manial Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator May Abo Elhasab mayaboelhasab@gmail.com 0223641088 Kasr Aliany Manial
City Postal code Country Position/Affiliation
Cairo Egypt assisstant lecturer
Role Name Email Phone Street address
Public Enquiries Gihan Abo Elwafa gigi2012chest@gmail.com 0223641088 Kasr Alainy Manial
City Postal code Country Position/Affiliation
Cairo Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elnady hakimnady@hotmail.com 0223641088 Kasr Alainy Manial
City Postal code Country Position/Affiliation
Cairo Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Hebatallah assal Hebatallah.assal@kasralainy.edu.eg 0223641088 Kasr Alainy Manial
City Postal code Country Position/Affiliation
Cairo Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported , after deidentification (text, tables, figures, and appendices) Informed Consent Form after publication data will be requested from corresponding author after publication
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