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.: PACTR202003901053053 Date of Approval: 02/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of real-time tracheal ultrasound versus colorimetric capnography as a point of care tool for confirmation of endotracheal intubation; randomized controlled study
Official scientific title Evaluation of real-time tracheal ultrasound versus colorimetric capnography as a point of care tool for confirmation of endotracheal intubation; randomized controlled study
Brief summary describing the background and objectives of the trial Endotracheal intubation is necessary for definitive airway control during general anesthesia or resuscitation of the critically ill patient. Unrecognized misplacement of the endotracheal tube can lead to devastating, avoidable morbidity and mortality. The end-tidal Carbon dioxide (ETCO2) detector works so well in the operating room that its use there is considered standard of care by anesthesiologists. Our objective is to compare two different techniques (colorimetric capnography Vs tracheal real-time ultrasound) as a point of care tools for confirmation of correct endotracheal intubation position.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/02/2020
Actual trial start date 05/02/2020
Anticipated date of last follow up 03/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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
Control Group colorimetric capnography nill 3 months The endotracheal tube place will be confirmed by “colorimetric co2 detector” where it is firstly applied to the ETT and colour changes are observed during mechanical ventilation where colour ranges are identified as follows: “A” range (Purple): approx. 0.03% to <0.5% EtCO2 (<4 mm Hg) “B” range (Beige): approx. 0.5% to <2.0% EtCO2 (4 to <15 mm Hg) “C” range (Yellow): approx. 2.0% to 5.0% EtCO2 (15 to 38 mm Hg) 35 Active-Treatment of Control Group
Experimental Group real time tracheal ultrasound nill 3 months The endotracheal tube place will be confirmed by “Real-time ultrasound linear probe” over the midline of the neck in which: ● The sonographer can watch as the tube passes into the trachea. Motion, will be visible just posterior to the tracheal cartilage during intubation. This is seen as an area of increased echogenicity. ● Additionally, the sonographer should watch for the appearance of a second air-mucosal interface adjacent to the trachea, which would indicate passage of the endotracheal tube into the oesophagus. If no second air-mucosal interface is appreciated, the tube has been correctly placed in the trachea. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients age ≥ 18 years, 2. ASA I or II. 3. Surgery requiring general anesthesia with endotracheal tube insertion. 1. Patients age < 18 years, 2. Mallampati score more than or equal to 3, thyromental distance less than 6 cm, neck circumference more than 40 cm or history of difficult airway. 3. Pregnancy. 4. Significantly severe cardiorespiratory pathology. 5. Any midline neck swelling. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 22/01/2020 Faculty of Medicine ain shams Univrsity Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
38, Ramsis Street, Abbasya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sensitivity and specificity of ultrasound against colorimetric capnography detector during and immediately after endotracheal intubation
Secondary Outcome Time of the manoeuvre from enotracheal tube insertion to confirmation of its place. starting confirmation by either device till the end of confirmation process
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Ramsis street, Abbasya Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tamer Nabil Abdelrahman 366, Dr. Mohamed badawy street, 2nd district 6th october city Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamer Nabil 366, Dr.Mohamed Badawy st 6th October city Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
wessam Zaher Alrazy street cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Abdelrahman tamernabil610@gmail.com +201288992910 366, Dr.Mohamed Badawy st, 2nd district
City Postal code Country Position/Affiliation
6th October city Egypt lecturer of anesthesia Ain Shams faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Fathy Tash Viced.research@med.asu.edu.eg 20226857539 Ramsis street, Abbasya
City Postal code Country Position/Affiliation
Cairo Egypt Head of research ethics comittee faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries tamer Abdelrahman tamernabil610@gmail.com +201288992910 366 Dr.Mohamed Baday st, 2nd district
City Postal code Country Position/Affiliation
6th october city Egypt lecturer of anesthesiaintensive care and pain faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes excel sheet Statistical Analysis Plan twelve monts Editors of journal to be submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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