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.: PACTR201708002460428 Date of Approval: 23/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title endotracheal intubation in nonophthalmic surgery
Official scientific title Stress response and intubation criteria in non-ophthalmic surgery: Airtraq versus Macintosch laryngoscopes
Brief summary describing the background and objectives of the trial Endotracheal intubation using direct laryngoscopy continues to be the gold standard amongst all the techniques for isolating the airway. Generally this is a secure manoeuvre, but it might become a situation of extreme emergency when dealing with an unexpected difficult airway. The Airtraq laryngoscope is claimed to be easy to learn to use and simple to handle, thus it is a practical device in many situations where managing the airway is indicated. Its advantages over the Macintosh laryngoscope have been demonstrated in patients with an airway that it is difficult to manage and in adverse situations outside the surgical setting, when endotracheal intubation has been achieved in a simple way following unsuccessful attempts with conventional laryngoscopes.The aim of this study is to compare the use of the Airtraq laryngoscope versus the Macintosh laryngoscope for routine orotracheal intubation with ordinary cuffed ETT in patients undergoing non ophthalmic surgery in terms of stress response, intraocular pressure changes, intubation time, complications during and after laryngoscopy, and ease of use.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied airway management,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 10/09/2017
Actual trial start date 25/09/2017
Anticipated date of last follow up 15/12/2017
Actual Last follow-up date 20/12/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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 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 group A intubation with the Airtraq laryngoscope 35
Experimental Group group B intubation with the traditional curved Macintosh laryngoscope blade 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists status I¿III. Scheduled to undergo various types of elective surgery requiring orotracheal intubation ophthalmic surgery patients with raised intraocular pressure, The need for endotracheal tubes that are armored, cranial-facing or caudal-facing, as indicated by the type of surgery, Inadequate mouth opening, Need for rapid sequence induction, Risk of gastric acid aspiration, Suspicion of difficult intubation ( mallampati class>I, interincisor distance<4cm, thyromental distance<6.5 cm, limited neck extension), History of an impossible or difficult intubation, Cervical spine pathology or neck flexion limitaion. Patients with hypertension and/or on ¿ blocker therapy. 20 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 27/06/2017 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The first attempt success rate (correct placement of the ETT within the first 60 seconds and before desaturation to < 94%) once
Primary Outcome The intubation time (total time from inserting the laryngoscope between the central incisors till appearance of capnography trace). once
Primary Outcome The time to best laryngoscopic view (the time from inserting the laryngoscope between the central incisors till achieving the best view for endotracheal intubation). The time to best laryngoscopic view (the time from inserting the laryngoscope between the central incisors till achieving the best view for endotracheal intubation). once
Primary Outcome Systolic, diastolic and mean arterial blood pressure, heart rate, intraocular pressure and entropy: baseline (prior to induction of anaesthesia), post induction (immediately prior to laryngoscopy), every 30 seconds during laryngoscopy, immediately prior to ETT insertion, immediately after intubation, 1 & 2 & 3 minutes after intubation.
Primary Outcome Serum epinephrine, glucose and cortisol Serum epinephrine, glucose and cortisol before induction and 2 minutes after intubation.
Secondary Outcome need for assistance (external laryngeal manipulation, gum elastic bougie and/or using other laryngoscope blade size), once
Secondary Outcome number of attempts till correct intubation once
Secondary Outcome complications during laryngoscopy & intubation (bleeding in the larynx , blood staining of the laryngoscope blade, injuries in the oral cavity (tongue, lips and teeth) laryngoscopy & intubation
Secondary Outcome complications after extubation (hoarseness of voice, airway injuries, swelling of the larynx , laryngospasm ) after extubation
Primary Outcome POGO score Once during larngoscopy with best view
Primary Outcome POGO score Once during larngoscopy with best view
Secondary Outcome esophageal intubation Once
Primary Outcome POGO score Once during larngoscopy with best view
Secondary Outcome esophageal intubation Once
Primary Outcome POGO score Once during larngoscopy with best view
Secondary Outcome esophageal intubation Once
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
khaled gaballah 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Public Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
Role Name Email Phone Street address
Scientific Enquiries sabry abdallah sabryabdallah222@yahoo.com 00201012378888 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt lecturer in aneaesthesia and intesnive care
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information