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.: PACTR201712002869388 Date of Approval: 14/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Can novel airway devices attenuate hemodynamic stress response to endotracheal intubation? A comparative study between the King Vision Video Laryngosc
Official scientific title Can novel airway devices attenuate hemodynamic stress response to endotracheal intubation? A comparative study between the King Vision Video Laryngoscope and glidescope.
Brief summary describing the background and objectives of the trial Eighty-eight patients with American Society of Anesthesiologists status I to II and aged ¿18 years who were scheduled for elective surgery under general anesthesia and had no predictors of difficult airway. Patients were randomized (44 per group) to undergo intubation using either King Vision video laryngoscopy (KVVL) or glidoscope. success rate, number of attempts, time to intubation, visualization of the glottis, and presence of complications were measured.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied endotracheal intubation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/01/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 15/04/2018
Actual Last follow-up date 15/04/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group kingvision intubation during induction of gereal anaesthesia during induction of gereal anaesthesia 44
Experimental Group glidoscope intubation during induction of gereal anaesthesia during induction of gereal anaesthesia during induction of gereal anaesthesia 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with ASA I and II,Aged 18-60 years patients refusal,difficult intubation 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 01/10/2017 Research Ethics Committee, Quality Assurance Unite, Tanta University, faculty of medicine,
Ethics Committee Address
Street address City Postal code Country
algish tanta 1234 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes were time to intubation and rate of successful intubation. Primary outcomes were time to intubation and rate of successful intubation.
Secondary Outcome Secondary outcomes were the percent of glottic opening and Cormack-Lehane grade visualized. Secondary outcomes were the percent of glottic opening and Cormack-Lehane grade visualized.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital algish tanta 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor nagat S. Elshmaa alstat tanta 12345 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nagat S. Elshmaa alstat tanta 12345 Egypt
mohamed elkaslan algish tanta 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nagat elshmaa nagat_elshmaa@yahoo.com 00201211865637 alstat
City Postal code Country Position/Affiliation
tanta 12345 Egypt aasistant professor in tanta university hospital
Role Name Email Phone Street address
Public Enquiries doaaelamrousy elamrousy doaamoha@yahoo.com 00101222364989 algish
City Postal code Country Position/Affiliation
tanta 12345 Egypt aasistant professor in tanta university hospital
Role Name Email Phone Street address
Scientific Enquiries mohamed elkashlan doaamoha@yahoo.com 00101222364989 algish
City Postal code Country Position/Affiliation
tanta 12345 Egypt doctor
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information