AnesthesiaPhase 2/3I-gelvsAir-qNCT02757820
A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway
A Phase 2/3 study testing LMA Classic, i- gel and Air-Q in people with Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this randomized trial will be to evaluate the clinical performance of the I-gel, air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- LMA Classic, i- gel and Air-Q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2016to Apr 2018
- Phase
- Phase 2/3
- 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 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight: 15-30 kg. Age: 2-9 years. Sex: both males and females. ASA physical status: 1-3. Operation: elective outpatient surgery in which airway management with a LMA would be appropriate.
Who cannot join
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia, Potentially difficult airway. Patients with history of neck, respiratory, or digestive tract pathology. Patients with gastroesophageal reflux, gastrointestinal stenosis or stricture
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university Pediatric hospital
Asyut, Assiut Governorate, 715715
About this study
Official title: A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway in Terms of Clinical Performance and Fiber Optic Glottic View
The aim of this randomized trial will be to evaluate the clinical performance of the I-gel, air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery under general anesthesia.
Read the detailed description
The laryngeal mask airway (LMA) Classic has gained popularity for airway management in both anesthesia and resuscitation due to its ease of use. However, insertion of the LMA Classic is not always easy in children due to differences in airway anatomy compared with adults, and more complications are related to its use in younger children compared with adults.
The i-gel has been commercially available in sizes suitable for children since 2010. It has a non-inflatable cuff and an additional lumen for the active or passive drainage of gastric contents (except in size 1). It is available in four children's sizes (1, 1.5, 2 and 2.5).
The air-Q_ ILA, is easily inserted with the index finger of the right hand, while the anesthetist performed jaw's lift with left hand, without a rotational technique (Jagannathan N et al., 2011, Dar long et al, 2014 and Keil et al, 2015).
Oropharyngeal leak pressure is defined as the airway pressure at which air leaks into the mouth or enters the stomach (Hughes et al., 2012). This feature is the most common primary outcome parameter used to evaluate the safety and efficacy of supraglottic airway devices because high pressures generally indicate that adequate ventilation can be achieved without air leakage during positive pressure ventilation at high inspiratory pressures (Teoh et al., 2010).
- Conditions
- Anesthesia
- Being tested
- LMA Classic, i- gel, Air-Q
- Keywords
- anesthesia; airway; laryngeal mask airway; I-gel; Air-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA ClassicDevice
Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.
i- gelDevice
Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
Air-QDevice
Patients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| LMA classic | Active comparator | Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air. Receives: Device: LMA Classic |
| I-gel | Active comparator | Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. Receives: Device: i- gel |
| Air-Q | Active comparator | Patients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. Receives: Device: Air-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway leak pressure
Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak pressure". If leak pressure reached 35 cmH2O, the expiratory valve will be opened. After adjusting the APL valve to 35 cmH2O, the maximum tidal volume (TVmax) will be measured by squeezing the balloon of anesthesia circuit until an audible leak occurred. Airway pressures were not allowed to exceed 35 cmH2O.
Measured: intraoperative
Secondary outcomes (4)
Fiberoptic laryngoscopic view
Fiberoptic images will be recorded using a digital camera and will be stored on a personal computer for grading by an independent anesthetist. The images will be graded with a score from 1 to 5, which has been defined and proposed previously (Beringer et al, 2011 and Lee et al, 2012); (grade 1-only larynx seen; grade 2-larynx and epiglottis posterior surface seen; grade 3-larynx and epiglottis tip of anterior surface seen, <50%visual obstruction of epiglottis to larynx; grade 4-epiglottis down folded and its anterior surface seen, >50%visual obstruction of epiglottis to larynx; and grade 5-epiglottis down folded and larynx cannot be seen directly).
Measured: intraoperative
ventilation score
the ventilation score which is scored from 0 to 3 based on three criteria: no leakage with an airway pressure of 15 cm H2O, bilateral chest excursions with a peak inspiratory pressure of 20 cm of H2O, and a square wave capnogram, with each item scoring 0 or 1 point (Sanuki et al., 2011). Thus, if all three criteria are satisfied, the ventilation score is 3.
Measured: intraoperative
Heart rate
the heart rate will be recorded from the monitor screen noninvasively.
Measured: intraoperative
peripheral arterial oxygenation
the peripheral arterial oxygenation will be recorded non invasively from pulse oximeter placed in the finger
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start14 Jun 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assistant professor, anesthesia department, faculty of medicine, Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757820
- Sponsor's protocol ID
- IRB00008718/ref. 89
- Acronym
- I-gelvsAir-q
- Status last verified
- Jan 2019
- First submitted
- 28 Apr 2016
- Last updated
- 7 Jan 2019
- 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 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway in Terms of Clinical Performance and Fiber Optic Glottic View
- ClinicalTrials.gov ID
- NCT02757820
- Acronym / sponsor ID
- I-gelvsAir-q / IRB00008718/ref. 89
- Conditions
- Anesthesia
- Keywords
- anesthesia; airway; laryngeal mask airway; I-gel; Air-Q
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 May 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.
The aim of this randomized trial will be to evaluate the clinical performance of the I-gel, air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery under general anesthesia.
Detailed description
The laryngeal mask airway (LMA) Classic has gained popularity for airway management in both anesthesia and resuscitation due to its ease of use. However, insertion of the LMA Classic is not always easy in children due to differences in airway anatomy compared with adults, and more complications are related to its use in younger children compared with adults.
The i-gel has been commercially available in sizes suitable for children since 2010. It has a non-inflatable cuff and an additional lumen for the active or passive drainage of gastric contents (except in size 1). It is available in four children's sizes (1, 1.5, 2 and 2.5).
The air-Q_ ILA, is easily inserted with the index finger of the right hand, while the anesthetist performed jaw's lift with left hand, without a rotational technique (Jagannathan N et al., 2011, Dar long et al, 2014 and Keil et al, 2015).
Oropharyngeal leak pressure is defined as the airway pressure at which air leaks into the mouth or enters the stomach (Hughes et al., 2012). This feature is the most common primary outcome parameter used to evaluate the safety and efficacy of supraglottic airway devices because high pressures generally indicate that adequate ventilation can be achieved without air leakage during positive pressure ventilation at high inspiratory pressures (Teoh et al., 2010).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LMA classic | Active comparator | Device: LMA ClassicPatients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air. |
| I-gel | Active comparator | Device: i- gelPatients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. |
| Air-Q | Active comparator | Device: Air-QPatients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Weight: 15-30 kg. Age: 2-9 years. Sex: both males and females. ASA physical status: 1-3. Operation: elective outpatient surgery in which airway management with a LMA would be appropriate.
Key exclusion criteria (1 listed)
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia, Potentially difficult airway. Patients with history of neck, respiratory, or digestive tract pathology. Patients with gastroesophageal reflux, gastrointestinal stenosis or stricture
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 |
|---|---|---|
| LMA ClassicPatients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air. | Device | LMA classic |
| i- gelPatients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. | Device | I-gel |
| Air-QPatients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer. | Device | Air-Q |
Primary outcome
Airway leak pressure
Time frame: intraoperative
Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak pressure". If leak pressure reached 35 cmH2O, the expiratory valve will be opened. After adjusting the APL valve to 35 cmH2O, the maximum tidal volume (TVmax) will be measured by squeezing the balloon of anesthesia circuit until an audible leak occurred. Airway pressures were not allowed to exceed 35 cmH2O.
4 secondary outcomes
Fiberoptic laryngoscopic view
Time frame: intraoperative
ventilation score
Time frame: intraoperative
Heart rate
Time frame: intraoperative
peripheral arterial oxygenation
Time frame: intraoperative
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 7 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Hala S Abdel-Ghaffar, MD principal investigator
Assistant professor, anesthesia department, faculty of medicine, Assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LMA Classic, i- gel and Air-Q in people with Anesthesia, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 7 Jan 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: intraoperative). 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 7 Jan 2019.