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.: PACTR202309463279793 Date of Approval: 19/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Does Fekry airway device enhance fiberoptic endotracheal intubation in obese patients lying in modified ramped position?
Official scientific title Does Fekry airway device enhance fiberoptic endotracheal intubation in obese patients lying in modified ramped position? A randomized controlled trial
Brief summary describing the background and objectives of the trial Endotracheal intubation is not always a complication-free procedure. Recently, fiberoptic intubation (FOI) with flexible fiberoptic bronchoscope is essential during difficult airway management in awake, sedated, and anesthetized patients. The fiberoptic bronchoscope (FOB) is one of the commonest instruments used in difficult airway management states as it minimizes the oropharyngo-laryngeal stimulation and attenuates the hemodynamic stress response. The use of different oropharyngeal airways or supraglottic airway devices (SGAD) as a conduit for tracheal intubation makes FOB intubation easier. There are several oropharyngeal airways that can be used for FOB intubation like Berman, Wiliams and modified Williams (Fekry) airways. Successful endotracheal intubation requires appropriate positioning of head and neck. Sniffing position had been described as the most appropriate and suitable head position for endotracheal intubation. In obese patients, it is recommended to make the patient in ramped position (by putting the back-up with the tragus of the ear at the same level of the suprasternal notch) in addition to applying the sniffing head and neck position. In addition, the anesthetist can use a special pillow to make a modified ramped position in which the shoulders are elevated and the neck is extended to make the patient's chest away from laryngoscopy. The patient will be positioned so that the tip of last spinous process (C7) is at the edge of the pillow. Neck will be extended to the most possible range. No previous study was conducted to compare between endotracheal intubation in modified ramped position using fiberoptic bronchoscopy only and endotracheal intubation in modified ramped position using fiberoptic bronchoscopy with the help of Fekry airway as a conduit. Therefore, this study aimed to assess the effect of using Fekry airway in facilitation of fiberoptic endotracheal intubation in obese patients.
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 Supportive care
Anticipated trial start date 01/08/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 12/09/2023
Anticipated target sample size (number of participants) 54
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Flexible fiberoptic bronchoscopy plus Fekry airway group. Starting from the moment of the inserting the flexible fiberoptic bronchoscopy between the teeth till passage of the endotracheal tube between the vocal cords. The patients will be intubated with flexible fiberoptic bronchoscopy with Fekry airway as a conduit. 27
Control Group Flexible fiberoptic bronchoscopy only group. Starting from the moment of the inserting the flexible fiberoptic bronchoscopy between the teeth till passage of the endotracheal tube between the vocal cords. The patients will be intubated with flexible fiberoptic bronchoscope with no conduit devices. 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Scheduled for elective surgeries under General anesthesia requiring endotracheal intubation Age between 18 and 50 years ASA physical status I–II Obesity (BMI between 30 and 40 kg/m2) Ganzouri scoring below 4 Inability to give a written consent ASA physical status more than II Age < 18 years old or > 50 years Pregnancy BMI < 30 Kg/m2 Loose teeth Situations which require a rapid sequence induction If any special endotracheal tube is needed for the case Emergency surgeries Documented or suspected difficult airway Obstructive sleep apnea Neck or upper respiratory tract abnormalities or facial deformities that invalidate Ganzouri airway score Active cardiac or chest problems Risk of aspiration Ganzouri airway score 4 or more Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 11/07/2021 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Al Ainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time of successful intubation Starting from the moment of the inserting the flexible fiberoptic bronchoscopy between the teeth till passage of the endotracheal tube between the vocal cords
Secondary Outcome Rate of first-time successful intubation The successful trial to be done within maximum 60 seconds
Secondary Outcome Intubation success in a second trial if needed The successful trial to be done within maximum 60 seconds
Secondary Outcome Glottic view using Cromack and Lehane’s scale At the same moment the bronchoscope reaches the laryngeal view
Secondary Outcome Stress response during intubation Baseline, 3 minutes after intubation, and 5 minutes after intubation
Secondary Outcome Intraoperative complications (aspiration, bleeding, arterial desaturation (spo2<92%) or airway injury) within the 60 seconds interval of the intubation trial
Secondary Outcome Postoperative complications (sore throats) within the first 3 hours after extubation in the postoperative care unit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospital Kasr Al Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Samir Awad Elkahwagy Kasr Al Ainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospital Kasr Al Ainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashraf Aswa ashrafrady83@gmail.com +201222139572 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor at the Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Bassant Abdelhamid bassantmohamed197@yahoo.com +201224254012 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at the Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmed Elkahwagy dr.researcher@gmx.com +201008390999 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/09/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/09/2023 Result - 16/09/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information