Airway DevicesNCT04021407
Laryngeal Mask Airway Versus Air Q Laryngeal Airway
A study testing LMA group and AirQ group in people with Airway Devices, run by Menoufia University at 1 site in Egypt.
Trial summary
Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Devices
- What is being tested?
- LMA group and AirQ group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Jun 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sex
- Age: 18-60 years
- ASA I-II
- Patients scheduled for dacryocystorhinostomy surgery
Who cannot join
- Any pathology of the neck, upper respiratory tract, upper alimentary tract
- Patients with a history of gastric regurgitation, heartburn
- Morbid obese,
- Patients with esophageal reflux (hiatus hernia)
- Anticipating difficult airway management
- Patients with coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laryngeal Mask Airway Versus Air Q Laryngeal Airway in Dacryocystorhinostomy
Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.
Read the detailed description
72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group according to supraglottic devices used. The following parameters were recorded in both studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or ETT was recorded with absence or presence of surgical blood on The undersurface of the device used.
- Conditions
- Airway Devices
- Being tested
- LMA group, AirQ group
- Keywords
- AirQ, LMA, dacrocystorhinostomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA groupDevice
patients were ventilated with LMA
AirQ groupDevice
patients were ventilated with AirQ airway
| Study group | Role | What they receive |
|---|---|---|
| LMA | Active comparator | 36 patients were ventilated with LMA during dacryocystorhinostomy surgery Receives: Device: LMA group |
| AirQ | Active comparator | 36 patients each were ventilated with air Q airway during dacryocystorhinostomy surgery Receives: Device: AirQ group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oro pharyngeal leak pressure in (cmH2O)
By setting the pop-off valve to limit peak airway pressure to 40 cm H2O and allowing airway pressure to increase at a fresh gas flow of 3 L/min until audible noise was heard over the mouth and no further increase in airway pressure is observed.
Measured: Just after insertion of supraglottic airway devices
Secondary outcomes (1)
Leak fraction in (%)
Leak fraction in (%)( Leak was calculated by subtracting the expiratory volume from the inspiratory volume and expressed as a fraction of the inspiratory volume). were evaluated just before surgery
Measured: Just after insertion of supraglottic airway devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Apr 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway DevicesStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashraf magdy eskandr, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021407
- Sponsor's protocol ID
- LMA versus Air Q
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Mask Airway Versus Air Q Laryngeal Airway in Dacryocystorhinostomy
- ClinicalTrials.gov ID
- NCT04021407
- Acronym / sponsor ID
- LMA versus Air Q
- Conditions
- Airway Devices
- Keywords
- AirQ, LMA, dacrocystorhinostomy surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 16 Jul 2019 (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.
Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.
Detailed description
72 patients were divided into two groups, 36 patients each, named LMA group, and air Q group according to supraglottic devices used. The following parameters were recorded in both studied groups, continuous Electrocardiography (ECG), heart rate (HR), means arterial pressure (MAP), arterial oxygen saturation (SpO2), end tidal carbon di-oxide (PCO2)..Oro pharyngeal leak pressure in (cmH2O), exhaled tidal volume in (ml), leak volume in (ml), leak fraction in (%) number of shifting from LMA to air Q or ETT and shifting from air Q to LMA or ETT was recorded with absence or presence of surgical blood on The undersurface of the device used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| LMA | Active comparator | Device: LMA group36 patients were ventilated with LMA during dacryocystorhinostomy surgery |
| AirQ | Active comparator | Device: AirQ group36 patients each were ventilated with air Q airway during dacryocystorhinostomy surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sex
- Age: 18-60 years
- ASA I-II
- Patients scheduled for dacryocystorhinostomy surgery
Key exclusion criteria (6 listed)
- Any pathology of the neck, upper respiratory tract, upper alimentary tract
- Patients with a history of gastric regurgitation, heartburn
- Morbid obese,
- Patients with esophageal reflux (hiatus hernia)
- Anticipating difficult airway management
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 grouppatients were ventilated with LMA | Device | LMA |
| AirQ grouppatients were ventilated with AirQ airway | Device | AirQ |
Primary outcome
Oro pharyngeal leak pressure in (cmH2O)
Time frame: Just after insertion of supraglottic airway devices
By setting the pop-off valve to limit peak airway pressure to 40 cm H2O and allowing airway pressure to increase at a fresh gas flow of 3 L/min until audible noise was heard over the mouth and no further increase in airway pressure is observed.
1 secondary outcome
Leak fraction in (%)
Time frame: Just after insertion of supraglottic airway devices
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 16 Jul 2019.
- Individual participant dataSharing planned: No
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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.
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 group and AirQ group in people with Airway Devices, run by Menoufia 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 4 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 16 Jul 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.
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?
Oro pharyngeal leak pressure in (cmH2O) (time frame: Just after insertion of supraglottic airway devices). 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 16 Jul 2019.