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.: PACTR201801002947288 Date of Approval: 06/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-guided Percutaneous Dilatational Tracheostomy Versus Fiber- optic Bronchoscopy-guided Percutaneous Dilatational Tracheostomy In Critically
Official scientific title Ultrasound-guided Percutaneous Dilatational Tracheostomy Versus Fiber- optic Bronchoscopy-guided Percutaneous Dilatational Tracheostomy In Critically Ill Patients
Brief summary describing the background and objectives of the trial To evaluate the safety and the efficacy of real time ultrasound guided PDT compared to bronchoscopy-guided PDT in critically ill patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied intubated patients
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2018
Actual trial start date 01/03/2018
Anticipated date of last follow up 01/03/2020
Actual Last follow-up date 01/03/2020
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 30
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
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 envelop Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guided bedside dilatational tracheostomy ultrasound guided bedside dilatational tracheostomy 15
Control Group bronchoscopic guided percutanous dilatational tracheostomy bronchoscopic guided percutanous dilatational tracheostomy 15 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ¿18 years old patient intubated ± mechanically ventilated and indicated for tracheostomy a) Patients who have unsuitable anatomy to do PDT(i.e.,short neck,tracheal deviation,cervical anatomical anomaly,previous cervical surgery,cervical trauma,cervical tumours) b) Inability to perform neck extension . c) Vitally unstable patients d) PC<50% e) Platelet count <80,000 f) P/ F ratio < 150 g) Patients whose trachea couldn't be intubated with an ET size >7.5 ID h) Patient / 1st of kin refusing the procedure. 18 Year(s) 100 Year(s) Male
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 08/10/2017 Faculty of Medicine, Beni Suef University, Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mohammed hasan ST beni suef 62515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome number and severity of complications complications within 2 weeks after the procedures
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
benisuef university hospital 24 Mohammed Hasan street benisuef 62515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
beni suef university hospital 24 Mohammed Hasan street benisuef 62515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor beni suef university hospital 24 Mohammed Hasan street benisuef 62515 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
dr sameh el maraghi 24 Mohammed Hasan street benisuef 62515 Egypt
dr ashraf khalid 24 Mohammed Hasan street benisuef 62515 Egypt
dr mohammed farouk 24 Mohammed Hasan street benisuef 62515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa abd elhameed icupioneer@gmail.com 02-01093965540 keman Al Arous-Elwasta
City Postal code Country Position/Affiliation
beni suef 62819 Egypt assisstant lecturer
Role Name Email Phone Street address
Public Enquiries Shaimaa abd elhameed icupioneer@gmail.com 02-01093965540 keman Al Arous-Elwasta
City Postal code Country Position/Affiliation
beni suef 62819 Egypt assisstant lecturer
Role Name Email Phone Street address
Scientific Enquiries Shaimaa abd elhameed icupioneer@gmail.com 02-01093965540 keman Al Arous-Elwasta
City Postal code Country Position/Affiliation
beni suef 62819 Egypt assisstant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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