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.: PACTR201802003065126 Date of Approval: 08/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between Airtraq, King Vision video laryngoscope, and the Macintosh laryngoscope
Official scientific title Alternative airways challenges to difficult intubation scenario in well controlled hypertensive adult patients with vocal cord polyp.comparison between Airtraq, King Vision video laryngoscope, and the Macintosh laryngoscope. A Prospective randomized study.
Brief summary describing the background and objectives of the trial There were many alternative methods for difficult intubation cases as direct laryngoscope with elastic stylet, airway scope, McCoy laryngoscope ,fiberoptic laryngoscope, C-trach,intubating laryngeal mask Bullard laryngoscope .C Mac D blade video laryngoscope and king vision video
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied difficult intubation scenario in well controlled hypertensive adult patients with vocal cord polyp.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/02/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 01/08/2018
Actual Last follow-up date 01/08/2018
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
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 Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group I ; intubation was done by Airtraq Airtraq could enhance the vision of larynx, less force needed than direct laryngoscope, less hemodynamic stress response to intubation and blade of laryngoscope, however it had certain disadvantages like possibility of blurred vision with secretions and short acquisition and maintenance costs 30
Experimental Group Group II intubation was done using king vision laryngoscopes King vision laryngoscope compromises of a 2.4 inches reusable display and a disposable rigid blade. There were two blade two blade types; one was a channeled blade that allow tracheal tube to be passed through the glottis and the other blade was a non- channeled blade that allow visualization of glottis and intubation was carried out using of metal stylet 30
Experimental Group Group III intubation was done by Macintosh laryngoscoes The ordinary laryngoscope had a restricted view of the airway structures that may not be obvious during trial to do intubation of trachea so endotracheal tube may be slipped into esophagus. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients included in this study were American Society of Anesthesiologist (ASA) I and II with well controlled hypertensive, aged 30-70 years and patients with mallampati grade III and IV were also included especially if they had mouth opening more than 18 mm. patients that excluded from this study were those at risk of pulmonary aspiration, coagulopathy, hepatic disorders with bleeding tendency, with history of any cardiac disorders, neck flexion deformity and patients with mouth opening less than 18 mm for males and 16 mm for female 30 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 01/01/2018 aswan university
Ethics Committee Address
Street address City Postal code Country
el seel street aswan 35127 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the number of intubation trials, the number of optimization maneuvers required (use of stylet, laryngeal manipulation) to help in tracheal intubation, the duration of successful intubation trials During tracheal intubation
Secondary Outcome the incidence of complications as mucosal trauma, misplacement of tube in esophagus, dental injury or bleeding and dental injury, hemodynamics parameters (heart rate, mean blood pressure) , and oxygen saturation were also recorded at baseline, post induction, immediately after intubation and at 1,3,5,10 minutes post intubation. During and after intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Aswan umiversity el seel street aswan 35127 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine aswan university el seel street aswan 35127 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal arafa el seel street aswan 35127 Egypt Funding Agency
Secondary Sponsor amir abozikary el sayed el seel street aswan 35127 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
sherif kamal arafa el seel street aswan 35127 Egypt
amir abozikary el sayed el seel street aswan 35127 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
Role Name Email Phone Street address
Scientific Enquiries sherif arafa sherifarafa1020@gmail.com 01005714014 el bahr street
City Postal code Country Position/Affiliation
tanta 35127 Egypt lecturer of anesthesia , icu .aswan university
REPORTING
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