Laryngeal MasksNCT02938039
I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures
A study testing Ambu LMA and I-Gel LMA in people with Laryngeal Masks, run by King Saud University.
Trial summary
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis. This study will add up to existing literature about the safety of LMA usage in neonates and infants. Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Laryngeal Masks
- What is being tested?
- Ambu LMA and I-Gel LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2016
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective surgical procedures
- No muscle relaxant agents
- No other comorbidities
Who cannot join
- Emergency surgical procedures
- Full stomach
- Subjects with upper respiratory tract infection
- Failed caudal block
About this study
Official title: I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.
This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.
Read the detailed description
Laryngeal mask airways (LMAs) 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 intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.
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). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.
- Conditions
- Laryngeal Masks
- Being tested
- Ambu LMA, I-Gel LMA
- Keywords
- laryngeal airways, infants, neonates, children, anesthetized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu LMADevice
Ambu Laryngeal Mask Airways
I-Gel LMADevice
I-Gel Laryngeal Mask Airways
| Study group | Role | What they receive |
|---|---|---|
| Ambu LMA | Active comparator | Ambu Laryngeal Mask Airway device of different sizes for age Receives: Device: Ambu LMA |
| I-Gel LMA | Active comparator | I-Gel Laryngeal Mask Airway device of different sizes for age Receives: Device: I-Gel LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Leak Pressure
It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely
Measured: 17 months
Secondary outcomes (6)
Effective airway time
It will be measured in seconds unit , and The time for successful insertion will be measured from the moment the facemask will be removed until attainment of first capnography upstroke after insertion
Measured: 18 months
Ease of insertion
The ease of placement of LMA will be assessed using a subjective scale of 1-4 (1 = no resistance and no maneuvers, 2 = mild resistance and one maneuver, 3 = moderate resistance and more than one maneuver, 4 = inability to place the device)
Measured: 18 months
Success at first attempt
The insertion will be labelled as a 'failure' if the device could not be successfully placed within two attempts or lacked a square-wave capnograph tracing, or if there was airway obstruction (e.g. oxygen desaturation < 90%, abnormal thoraco-abdominal movements, or obstructive noises or no rise of chest at all), inadequate ventilation (an inability to deliver a minimum of 7 ml.kg-1 tidal volumes, or an audible leak)
Measured: 18 months
Oxygen Desaturation less than 90%
It is a Yes or No outcome measure and it will be measured using the oxygen saturation monitor placed on finger and the reading will be detected on the capnography
Measured: 18 months
Gastric Insufflation
It is a Yes or No outcome measure and auscultation with a stethoscope will be performed over the epigastrium during leak pressure testing to detect the occurrence of gastric insufflation
Measured: 18 months
Manipulation of the Device
the number and type of airway manipulations (gentle advancement, withdrawal of device without removal, jaw thrust, or neck extension) required to maintain airway patency during the case will be recorded
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal MasksStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Abdulrahman Alzahem, King Saud University
- Investigators
- Abdulrahman M Alzahem, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938039
- Sponsor's protocol ID
- E14-1153
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02938039
- Acronym / sponsor ID
- E14-1153
- Conditions
- Laryngeal Masks
- Keywords
- laryngeal airways, infants, neonates, children, anesthetized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Oct 2016 (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.
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.
This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.
Detailed description
Laryngeal mask airways (LMAs) 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 intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.
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). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu LMA | Active comparator | Device: Ambu LMAAmbu Laryngeal Mask Airway device of different sizes for age |
| I-Gel LMA | Active comparator | Device: I-Gel LMAI-Gel Laryngeal Mask Airway device of different sizes for age |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elective surgical procedures
- No muscle relaxant agents
- No other comorbidities
Key exclusion criteria (4 listed)
- Emergency surgical procedures
- Full stomach
- Subjects with upper respiratory tract infection
- Failed caudal block
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 |
|---|---|---|
| Ambu LMAAmbu Laryngeal Mask Airways | Device | Ambu LMA |
| I-Gel LMAI-Gel Laryngeal Mask Airways | Device | I-Gel LMA |
Primary outcome
Airway Leak Pressure
Time frame: 17 months
It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely
6 secondary outcomes
Effective airway time
Time frame: 18 months
Ease of insertion
Time frame: 18 months
Success at first attempt
Time frame: 18 months
Oxygen Desaturation less than 90%
Time frame: 18 months
Gastric Insufflation
Time frame: 18 months
Manipulation of the Device
Time frame: 18 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 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Laryngeal Masks
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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.
Abdulrahman M Alzahem, MD principal investigator
King Saud University
Questions about this trial
What is this clinical trial studying?
A study testing Ambu LMA and I-Gel LMA in people with Laryngeal Masks, run by King Saud University.
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 3 inclusion and 4 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Airway Leak Pressure (time frame: 17 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 19 Oct 2016.