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.: PACTR201605001589209 Date of Approval: 15/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A randomized prospective study Comparing C-mac D-blade, Airtraq, and Fiberoptic bronchoscope for intubating patients with anticipated difficult airway
Official scientific title A randomized prospective study Comparing C-mac D-blade, Airtraq, and Fiberoptic bronchoscope for intubating patients with anticipated difficult airway
Brief summary describing the background and objectives of the trial A difficult airway is known as the clinical situation in which a well trained anesthesiologist experiences difficulty with face mask ventilation, difficulty with tracheal intubation, or both.1 Fiberoptic intubation using fiberoptic bronchoscope is the gold standard for the management of difficult intubation.2 The Airtraq (Prodol Meditec S.A., Vizcaya, Spain) laryngoscope is a new device for intubation of normal and the difficult airway.3 The C-MAC® video laryngoscope (Karl Storz GmbH & Co. KG, Tuttlingen Germany) uses Macintosh shaped blades. The small camera and a light source at the distal third of the blade enable visualization of the vocal cord on LCD monitor. The C-MAC® videolaryngoscope may be a useful alternative for routine and difficult airway management.4, 5 The C-MAC system introduced a new videolaryngoscopic blade with high angulation (D-Blade) to improve the management of difficult airway.6 The aim of the present study is to compare the use of C-MAC D-blade video laryngoscope, Airtraq laryngoscope, and fiberoptic bronchoscope for intubation of patient with predicted difficult airways during routine induction of anaesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 01/09/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
30753/02/16 research ethical committee, faculty of medicine, tanta university
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 Permuted block randomisation ( each block 40 ) Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation ( each block 40 ) Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation ( each block 40 ) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group C-mac D-blade instrument used for tracheal intubation 40
Experimental Group Airtraq instrument used for tracheal intubation 40
Experimental Group fiberoptic group instrument used for tracheal intubation 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients will be included in the study if they will have a predicted difficult airway as assessed by the presence of at least one of the following clinical predictors: mouth opening (interincisor distance) < 3.5 cm; thyromental distance < 6 cm, Mallampati score ¿ 3, limited mobility at the atlanto-occipital joint (< 15 ¿ ), according to Bellhouse & Dore.7 Mallampatti grade will be determined with the patient maximally protruding his tongue with the head in full extension during sitting position.8 Interincisor distance will be measured with the patient in sitting position, and thyromental distance will be measured from inside of the mentum to the thyroid cartilage with the head in full extension.9 Exclusion criteria will include patients require a nasal intubation, have ASA physical status IV or V, younger than 18 yr, have respiratory tract pathology or coagulation disorders, or are at risk of regurgitation-aspiration (known hiatus hernia, esophageal reflux, or not fasted). Also, patients with anticipated impossible intubation will be excluded [as patients with a history of impossible intubation, mouth opening (interincisor distance) less than 20 mm, or cervical spine fixed in flexion 14]. 18 Year(s) 80 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 28/02/2016 research ethical committee, faculty of medicine, Tanta university
Ethics Committee Address
Street address City Postal code Country
el geesh street tanta nopost code Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to tracheal intubation after tracheal intubation
Secondary Outcome Time required to visualize the vocal cords during tracheal intubation
Secondary Outcome The number of intubation attempts during tracheal intubation
Secondary Outcome The number of successful trial during tracheal intubation
Secondary Outcome - Complications during tracheal intubation
Secondary Outcome - Mean arterial blood pressure, heart rate and oxygen saturation will be recorded before induction, after induction, 1, 3 and 5 minutes after intubation.
Secondary Outcome - Lowest O2 saturation during tracheal intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital el geesh street tanta no post code Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital elgeesh street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hesham mohamed marouf el geesh street tanta no Egypt University
Secondary Sponsor Naglaa khalil yousef el geesh street tanta no Egypt University
COLLABORATORS
Name Street address City Postal code Country
hesham mohamed marouf el geesh street tanta no Egypt
Naglaa khalil yousef el geesh street tanta no Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hesham marouf heshammarouf@hotmail.com 00201274366808 hassan radwan street
City Postal code Country Position/Affiliation
tanta no Egypt associat professor
Role Name Email Phone Street address
Public Enquiries hesham marouf heshammarouf@hotmail.com 00201274366808 hassan radwan street, safeer tower
City Postal code Country Position/Affiliation
tanta no Egypt associate professor
Role Name Email Phone Street address
Scientific Enquiries naglaa khalil nagla.khalil2001@yahoo.com 00201273547762 el geesh street
City Postal code Country Position/Affiliation
tanta no Egypt lecturer of anesthesia and icu
REPORTING
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Result URL Hyperlinks
Changes to trial information