Operative Surgical ProceduresNCT02532465
Glottic View Using Supraglottic Devices in Pediatric Patients
A study testing Air-Q and i-gel in people with Operative Surgical Procedures, run by Senthil G. Krishna at 1 site in United States.
Trial summary
Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Operative Surgical Procedures
- What is being tested?
- Air-Q and i-gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.
- Conditions
- Operative Surgical Procedures
- Being tested
- Air-Q, i-gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-QDevice
i-gelDevice
| Study group | Role | What they receive |
|---|---|---|
| Air-Q | Active comparator | The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. Receives: Device: Air-Q |
| i-gel | Experimental | The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. Receives: Device: i-gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptable View of the Glottic Aperature (Grade I-II)
Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.
Measured: 15 seconds after insertion of Air-Q or i-gel
Secondary outcomes (2)
Airway Insertion Time
Amount of time it takes to insert airway.
Measured: Immediately after anesthesia induction
Time to Achieve Best Fiberoptic View
After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded.
Measured: 15 seconds after insertion of Air-Q or i-gel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion26 Jul 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Operative Surgical ProceduresStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senthil G. Krishna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Senthil G. Krishna, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532465
- Sponsor's protocol ID
- IRB15-00486
- Status last verified
- Jul 2019
- First submitted
- 21 Aug 2015
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glottic View Using Supraglottic Devices in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02532465
- Acronym / sponsor ID
- IRB15-00486
- Conditions
- Operative Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Senthil G. KrishnaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air-Q | Active comparator | Device: Air-QThe Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider. |
| i-gel | Experimental | Device: i-gelThe i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Air-Q | Device | Air-Q |
| i-gel | Device | i-gel |
Primary outcome
Acceptable View of the Glottic Aperature (Grade I-II)
Time frame: 15 seconds after insertion of Air-Q or i-gel
Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.
2 secondary outcomes
Airway Insertion Time
Time frame: Immediately after anesthesia induction
Time to Achieve Best Fiberoptic View
Time frame: 15 seconds after insertion of Air-Q or i-gel
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Operative Surgical Procedures
Recruiting
Post-Operative Cesarean Section Cosmesis
Cesarean Delivery
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
Active, not recruiting
Surgical Margin Assessment Using Intra-operative High-resolution PET/CT in Patients With Cancers Referred to Surgical Resection, an Exploratory Pilot Study
Breast Cancer, Head and Neck Cancers
Recruiting
Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery
Thoracic Surgical Procedures
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
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 Air-Q and i-gel in people with Operative Surgical Procedures, run by Senthil G. Krishna at 1 site in United States.
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 22 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acceptable View of the Glottic Aperature (Grade I-II) (time frame: 15 seconds after insertion of Air-Q or i-gel). 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 22 Aug 2019.