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.: PACTR202202567201966 Date of Approval: 10/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Perfusion Index, Intraocular Pressure, and Hemodynamic Responses to Insertion of Endotracheal Tube, Air-Q and Ambu Aura-I in Ophthalmic Surgeries: A Randomized Controlled Trial
Official scientific title Perfusion Index, Intraocular Pressure, and Hemodynamic Responses to Insertion of Endotracheal Tube, Air-Q and Ambu Aura-I in Ophthalmic Surgeries: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Supraglottic airway devices (SGADs) have become increasingly used to provide patients with a safe and efficient airway. SGADs are more advantageous than ordinary endotracheal intubation, such as avoiding of laryngoscopy, ease of insertion, better patient tolerance as well as being minimally invasive, less traumatic and provide more stable hemodynamics and intraocular pressure. The Air-Q laryngeal mask airway is a second generation supraglottic device. It is a viable device for providing proper breathing and serving as a conduit for endotracheal intubation. The Ambu Aura-I is a great alternative to the endotracheal tube for attaining and maintaining airway control during elective and emergency operations in patients who are candidates for a supraglottic airway or when alternative options aren't accessible or when other attempts to insert a secure airway have failed. Even though both devices are becoming more widely used, clinical studies on the impact of their implantation on the IOP and the cardiovascular system are insufficient. The aim of this trial was to assess the safety and efficacy of supraglottic airway devices (Air-Q / Ambu Aura-I) used to avoid stress response including increased intraocular pressure, heart rate, arterial blood pressure and decreased perfusion index during ophthalmic operations under general anesthesia.
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 Assessing the safety and efficacy of supraglottic airway devices compared to endotracheal intubation during ophthalmic operations under general anesthesia.
Anticipated trial start date 01/04/2018
Actual trial start date 01/04/2018
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 96
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Endotracheal intubation During the entire operation under general anesthesia. Using direct laryngoscopy, intubation of the trachea was tried with a cuffed tracheal tube (internal diameter 7 mm for women and 8 mm for men) 32 Active-Treatment of Control Group
Experimental Group Air Q device During the entire operation under general anesthesia. In the Air-Q group, the manufacturer's advice was used to establish the size. Women wore size 3.5, while most men wore size 4.5. The cuff was inflated to 5-10 cm3 of air. 32
Experimental Group Ambu Aura I During the entire operation under general anesthesia. In the Ambu Aura I group, patients weighing 30–50 kg were fitted with a size 3 device, patients weighing 50–70 kg with a size 4, and patients weighing more than 70 kg with a size 5. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients undergoing elective ophthalmic surgeries under general anesthesia American Society of Anesthesiologists physical status I or II Glaucoma Cardiovascular or pulmonary diseases Restriction of neck extension or mouth opening Pharyngeal pathology Obstruction of the airway at or below the level of the larynx Body mass index above 35 kg/m2 Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 11/12/2017 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The change in perfusion index Before insertion of the airway device and at 1, 2, 3, and 5 minutes after the airway device was inserted
Secondary Outcome The changes in systolic blood pressure, diastolic blood pressure, heart rate, and intraocular pressure Before insertion of the airway device and at 1, 2, 3, and 5 minutes after the airway device was inserted
Secondary Outcome The ease of insertion of the airway device During insertion of the airway device
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr A Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nadia Hamed Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nadia Hamed nadiahelmy59@hotmail.com +201225550439 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Gihan Obayah gihan.obaya@gmail.com +201111332343 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Nader Naguib nader.n.naguib22@gmail.com +201001199746 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study are 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
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information