Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMANCT04458064
I-gel Versus Air-Q LMA for Pediatric Patients
A study testing LMA i gel in people with Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA
- What is being tested?
- LMA i gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Jul 2020
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA grade I-II
- operative time of ≤60 minutes
Who cannot join
- age >10 years
- ASA grade ≥II
- current or recently resolved upper respiratory tract infection
- presence of oropharynx or laryngeal pathologies or congenital anomalies
- pathologies inducing reflux or increasing the possibility of aspiration
- allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or bronchial asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures
This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.
Read the detailed description
The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation.
The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.
- Being tested
- LMA i gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA i gelOther
Also called LMA Air Q
insertion of LMA for maintaining airway during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| i gel | Active comparator | I gel LMA was inserted for all patients Receives: Other: LMA i gel |
| Air Q LMA | Active comparator | Air Q LMA was inserted for all patients Receives: Other: LMA i gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supraglottic device success rate
Fitness of LMA for ventilation
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMAStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458064
- Sponsor's protocol ID
- ASUH1421/18
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures
- ClinicalTrials.gov ID
- NCT04458064
- Acronym / sponsor ID
- ASUH1421/18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- 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 targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.
Detailed description
The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation.
The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i gel | Active comparator | Other: LMA i gelI gel LMA was inserted for all patients |
| Air Q LMA | Active comparator | Other: LMA i gelAir Q LMA was inserted for all patients |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA grade I-II
- operative time of ≤60 minutes
Key exclusion criteria (6 listed)
- age >10 years
- ASA grade ≥II
- current or recently resolved upper respiratory tract infection
- presence of oropharynx or laryngeal pathologies or congenital anomalies
- pathologies inducing reflux or increasing the possibility of aspiration
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 i gelAlso: LMA Air Qinsertion of LMA for maintaining airway during anesthesia | Other | Air Q LMA, i gel |
Primary outcome
Supraglottic device success rate
Time frame: 60 minutes
Fitness of LMA for ventilation
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 Jul 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA i gel in people with Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA, run by Ain Shams 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 2 inclusion and 6 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 Jul 2020. 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.
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?
Supraglottic device success rate (time frame: 60 minutes). 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 Jul 2020.