Pediatric Laryngeal Mask AirwayNCT02494765
Spatial Relationship of I-gelTM and Ambu® AuraOnceTM on Paediatric Airway: A Comparison on Three Dimensional MRI
A study testing I-gel TM and Ambu AuraOnce (AO) in people with Pediatric Laryngeal Mask Airway and Spatial Relations With Pediatric Airway, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric and neonatal patients. The investigating hospital is one of the pioneers in providing this service in the Kingdom (which was established about 10 years ago) to the patients of this age group. Read more about this study
- Who is it for?
- Ages 1 day to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Laryngeal Mask Airway, Spatial Relations With Pediatric Airway, Assessed With Three Dimensional Magnetic Resonance Imaging
- What is being tested?
- I-gel TM and Ambu AuraOnce (AO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jul 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- After getting informed voluntary consent from the parents.
- American society of anesthesiologists (ASA) physical status I and II
- Age up to 12 years,
- Scheduled to undergo elective Magnetic resonance imaging (MRI) under General anesthesia (GA) for some medical or surgical disease of the -area (not involving oral cavity, larynx, pharynx and neck)
- Not likely to require use of muscle relaxants as MRI prerequisite (e.g breath holding).
Who cannot join
- Co-operative patients who will accept to undergo the procedure without anaesthesia
- Patients with upper respiratory tract infection, fever
- Known to be suffering from deformity of the face, larynx, pharynx or neck,
- Potentially difficult intubation,
- Full stomach patient,
- Contraindication to supraglottic device placement or GA,
- Failed supraglottic insertion or requiring emergency endotracheal intubation during the procedure -Patients whose trachea will already be intubated or will be having tracheostomy.-
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University, King Khalid University Hospital
Riyadh, 11472
About this study
At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric and neonatal patients. The investigating hospital is one of the pioneers in providing this service in the Kingdom (which was established about 10 years ago) to the patients of this age group. Only a small percentage of pediatric patients with age above 8 years accept the procedure to be done without anesthesia; and majority of MRI procedures are done under general anesthesia. The airway management of these patients is commonly accomplished with laryngeal mask airways (LMA).
LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and intra ocular pressure (IOP) stability.
Read more
There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel LMA and in King Khalid University Hospital (the investigating hospital) these two types are being used.
On search of literature the investigators found only one study in adults in which such comparison has been made and there was no study comparing different LMAs on the basis of their spatial effects on anatomical structures of the neck and airway in pediatric patients with age 12 years or below.
In this prospective randomized study, the investigators will compare the spatial relationship of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in pediatric patients undergoing 3-D MRI under general anesthesia (GA).
- Conditions
- Pediatric Laryngeal Mask Airway, Spatial Relations With Pediatric Airway, Assessed With Three Dimensional Magnetic Resonance Imaging
- Being tested
- I-gel TM, Ambu AuraOnce (AO)
- Keywords
- I-gelTM, Ambu® AuraOnceTM, supraglottic devices, laryngeal mask effects on airway, 3D magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel TMDevice
Airway management with I-gel
Ambu AuraOnce (AO)Device
Airway management with Ambu AuraOnce (AO)
| Study group | Role | What they receive |
|---|---|---|
| I-gelTM | Active comparator | I-gel is a supraglottic device made of gel like material. It is used for administration of anesthesia in selected patients. Receives: Device: I-gel TM |
| Ambu® AuraOnceTM | Active comparator | Ambu AuraOnce (AO) is a supraglottic device having different material and its shaft has greater curvature than I-gel. It is also used for administration of anesthesia in selected patients. Receives: Device: Ambu AuraOnce (AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on tongue
The thickness of the tongue will be defined as the greatest distance between the surface of the tongue and the lower margin of the geniohyoideus muscle measured on sagittal T2 midline images. Scale (mm).
Measured: After 2 months
Secondary outcomes (5)
Depth of intrusion of the tip of the supraglottic device into the Upper esophageal sphincter
The depth of insertion relative to the glottis will be defined as the perpendicular distance between a horizontal line through the level of the glottis and a parallel line touching the tip of the supraglottic device on sagittal images. Scale (mm).
Measured: After 2 months
Effect of Supraglottic devices on hyoid bone
The position of the hyoid bone relative to cervical spine will be determined by measuring the shortest distance between the dorsal margin of the hyoid bone and the ventral margin of the opposing vertebra body. Scale (mm).
Measured: After 2months
Effect of Supraglottic devices on glottic area
The glottic area and the axial diagonal of the glottis will be measured on axial T1 slices at the narrowest part of the glottis after the images has been reoriented to be parallel to the vocal cords and the enclosed glottic area. Scale (mm).
Measured: After 2 months
Effect of Supraglottic devices on distance between common carotids
The distance between the common carotids will be defined as the distance between the medial margins of the common carotid arteries measured on the same axial T1 section used to determine the glottic area. Scale (mm).
Measured: After 2 months
Effect of Supraglottic devices on the distance between the arytenoids
The distance between the arytenoid cartilages will be measured on an axial T1 plane realigned as described above, with the points of measurement being the most medial part of the vocal process. Scale (mm)
Measured: After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Laryngeal Mask AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Aqil, King Saud University
- Investigators
- Mansoor Aqil, MD, Principal investigator, King Saud University, King Khalid University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494765
- Sponsor's protocol ID
- E-14-1154
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Relationship of I-gelTM and Ambu® AuraOnceTM on Paediatric Airway: A Comparison on Three Dimensional MRI
- ClinicalTrials.gov ID
- NCT02494765
- Acronym / sponsor ID
- E-14-1154
- Conditions
- Pediatric Laryngeal Mask Airway, Spatial Relations With Pediatric Airway, Assessed With Three Dimensional Magnetic Resonance Imaging
- Keywords
- I-gelTM, Ambu® AuraOnceTM, supraglottic devices, laryngeal mask effects on airway, 3D magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric and neonatal patients. The investigating hospital is one of the pioneers in providing this service in the Kingdom (which was established about 10 years ago) to the patients of this age group. Only a small percentage of pediatric patients with age above 8 years accept the procedure to be done without anesthesia; and majority of MRI procedures are done under general anesthesia. The airway management of these patients is commonly accomplished with laryngeal mask airways (LMA).
LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and intra ocular pressure (IOP) stability.
There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel LMA and in King Khalid University Hospital (the investigating hospital) these two types are being used.
On search of literature the investigators found only one study in adults in which such comparison has been made and there was no study comparing different LMAs on the basis of their spatial effects on anatomical structures of the neck and airway in pediatric patients with age 12 years or below.
In this prospective randomized study, the investigators will compare the spatial relationship of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in pediatric patients undergoing 3-D MRI under general anesthesia (GA).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-gelTM | Active comparator | Device: I-gel TMI-gel is a supraglottic device made of gel like material. It is used for administration of anesthesia in selected patients. |
| Ambu® AuraOnceTM | Active comparator | Device: Ambu AuraOnce (AO)Ambu AuraOnce (AO) is a supraglottic device having different material and its shaft has greater curvature than I-gel. It is also used for administration of anesthesia in selected patients. |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- After getting informed voluntary consent from the parents.
- American society of anesthesiologists (ASA) physical status I and II
- Age up to 12 years,
- Scheduled to undergo elective Magnetic resonance imaging (MRI) under General anesthesia (GA) for some medical or surgical disease of the -area (not involving oral cavity, larynx, pharynx and neck)
- Not likely to require use of muscle relaxants as MRI prerequisite (e.g breath holding).
Key exclusion criteria (7 listed)
- Co-operative patients who will accept to undergo the procedure without anaesthesia
- Patients with upper respiratory tract infection, fever
- Known to be suffering from deformity of the face, larynx, pharynx or neck,
- Potentially difficult intubation,
- Full stomach patient,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-gel TMAirway management with I-gel | Device | I-gelTM |
| Ambu AuraOnce (AO)Airway management with Ambu AuraOnce (AO) | Device | Ambu® AuraOnceTM |
Primary outcome
Effect on tongue
Time frame: After 2 months
The thickness of the tongue will be defined as the greatest distance between the surface of the tongue and the lower margin of the geniohyoideus muscle measured on sagittal T2 midline images. Scale (mm).
5 secondary outcomes
Depth of intrusion of the tip of the supraglottic device into the Upper esophageal sphincter
Time frame: After 2 months
Effect of Supraglottic devices on hyoid bone
Time frame: After 2months
Effect of Supraglottic devices on glottic area
Time frame: After 2 months
Effect of Supraglottic devices on distance between common carotids
Time frame: After 2 months
Effect of Supraglottic devices on the distance between the arytenoids
Time frame: After 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor Aqil, MD principal investigator
King Saud University, King Khalid University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-gel TM and Ambu AuraOnce (AO) in people with Pediatric Laryngeal Mask Airway and Spatial Relations With Pediatric Airway, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on tongue (time frame: After 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.