AnesthesiaNCT04951089
Comparison of the Clinical Performances of Air-Q SP 3G and i-Gel
A study testing i-gel Supraglottic device insertion and Air-Q SP 3G Supraglottic device insertion in people with Anesthesia, run by Bnai Zion Medical Center.
Trial summary
Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- i-gel Supraglottic device insertion and Air-Q SP 3G Supraglottic device insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Oct 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient ASA ( American Society Anesthesiologist) I-II
- non pregnancy
Who cannot join
- Difficult airway
- pregnancy
About this study
Official title: Comparison of the Clinical Performances of Air-Q SP 3G and i-Gel by Novice Intubators During Manual In-line Neck Stabilization: A Randomized Controlled Trial
Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal. The Advance Trauma Life Support suggested the use of Supraglottic Airway Devise (SAD) in managing the difficult airway. The air-Q SP 3G was introduced as an alternative for managing the difficult airway. The i-gel is proposed as supraglottic device made of a medical grade thermoplastic elastomer. The unique design of both devices is that a cuff is not needed to be inflated .
A randomize controlled trail will be conduce. Participants will insert the both supraglottic devices to compare performance of ventilation and oxygenation of the patients.
Read more
The insertion will be performed on age 18-75 year patients, scheduled for elective surgery with general anesthesia. The SAD use in the study will be a single use i-gel size 4 or 5 and the air-Q SP 3G- size 4 or 5 For induction of anesthesia all patients will receive premedication. After 3 min of preoxygenation anesthesia will induce with up to 2 mcg/Kg fentanyl and 2-3 mg propofol Neuromuscular blockade will be obtained with rocuronion.
The participant will performed one insertion of the i-gel or the air-Q SP 3G on the patient while manual in-line stabilization of the neck Primary outcome: time to success insertion of SAD Secondary outcome : duration in seconds of insertion
Read the detailed description
In the combat setting, airway compromise is the second leading cause of preventable death after hemorrhage.
Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal.
Possible reasons for the failure in achieving definitive airway in trauma patients are the requirement for in-line stabilization of the neck, and the inexperience of the providers.
The Tactical Combat Casualty Care (TCCC) Guidelines recommend using a supraglottic airway device (SAD) as an option to assist in securing the airway in tactical evacuation phase of care.
In a recent published Randomized Control Trail in patients, the success of blind intubation did not support the use of tracheal intubation (TI) via iLTS-D by novice intubators. However, this study revealed a high success rate (84.6%) of iLTS-D placement in the oropharynx, associated with effective ventilation as confirmed by capnography.
The time to obtain successful iLTS-D placement in the oropharynx was 42 sec, which is 2.5 times shorter than the time to achieve TI with DL.
These results encourage the use of a second generation Supraglottic Airway Device (SAD) by novice intubators as the first airway intervention in trauma patients, who require immediate airway management.
SADs play a key role as primary and rescue devices in predicted and unanticipated difficult airway management, by providing both a patent airway for oxygenation and ventilation and a conduit for TI, thereby avoiding the disastrous outcomes of 'cannot intubate, cannot oxygenate' situations.
Recently study reported the effectiveness of initial insertion with Laryngeal Tube (LT) vs initial Endotracheal Intubation (ETI) in adults out of Hospital cardiac arrest (OHCA).This study concludes that a strategy of initial LT insertion was associated with significantly greater 72-hour survival compare with the strategy of initial ETI.
These findings suggest that SAD insertion may be considered as an initial airway management strategy in patients with OHCA.
The implication of the SAD effectivity in fasting rescue the airway pattern and reassure oxygenation is greatest importance in combat setting.
The self-pressurized air-Q intubating laryngeal airway (air-Q SP 3G) (Mercury Medical, Clearwater, FL, USA) is a single-use SAD that does not require cuff inflation. The original air-Q intubating laryngeal airway (Cookgas LLC; Mercury Medical) was designed to facilitate tracheal intubation through its lumen.
The air-Q SP 3G differs from the original air-Q by the absence of an inflatable cuff and the continuity between the airway tube and cuff through an inner aperture at the junction the airway tube and periglottic cuff of the air-Q SP 3G makes the intracuff pressure equilibrate dynamically with the airway pressure and is designed to adjust to the patient's pharyngeal and periglottic anatomy .
The absence of a pilot balloon and continuity between the airway tube and the cuff through an inner aperture has several clinical benefits when compared with other cuffed SAD.
First, the provider does not loose time with the inflation cuff maneuver. Second, intra-cuff pressures are determined by the airway pressures, because of the equalization of pressures with the movement of gas between the cuff and airway tube.
Third, lower intra-cuff pressures are maintained overall as a result of being limited by the peak airway pressures, with the highest pressures exerted during inspiration. Fourth, by not exceeding peak airway pressures, the balance between intra-cuff pressures and the airway seal of the device may be optimized at lower pressure. Therefore, the risk of sore throat, neuropraxic injury, and gastric insufflation seen with overinflation of traditional cuffed supraglottic devices may be reduced.
Recently, the air-Q SP 3G has been upgraded with the addition of the gastric channel in order diminish the risk of aspiration.
The i-gel second generation SAD, disposable airway (Intersurgical Ltd, Workingham, UK) is a SAD made of a medical grade thermoplastic elastomer. Its unique design does not need an inflatable cuff because the thermoplastic elastomer provides the seal. The i-gel is gaining a reputation for its ease of insertion and for its use in many clinical situations. Previous studies have demonstrated that the i-gel can be placed more faster than conventional laryngeal mask airways, which might play a role in prehospital settings. Other advantages of the i-gel are ease of training, cost, safety, and simplicity of use.
There have been no studies comparing these devices in patients with limited neck extension. Therefore, the aim is to compare the clinical performance of these two devices in adult patients with simulated cervical immobilization.
- Conditions
- Anesthesia
- Being tested
- i-gel Supraglottic device insertion, Air-Q SP 3G Supraglottic device insertion
- Keywords
- Supraglottic devices, Airway, Insertion success
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gel Supraglottic device insertionDevice
i-gel insertion for oxygenation
Air-Q SP 3G Supraglottic device insertionDevice
Air-Q SP 3G insertion for oxygenation
| Study group | Role | What they receive |
|---|---|---|
| i-gel supraglottic device insertion for oxygenation | Experimental | i-gel supraglottic device insertion for oxygenation i-gel supraglottic device insertion for oxygenation and ventilation Receives: Device: i-gel Supraglottic device insertion |
| Air-Q SP 3G supraglottic insertion for oxygenation | Experimental | Air-Q SP 3G supraglottic device insertion for oxygenation Air-Q SP 3G supraglottic device insertion for oxygenation and ventilation Receives: Device: Air-Q SP 3G Supraglottic device insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion success ratio between supraglottic device the i-gel and Air-Q SP 3G Comparison of the insertion success in the oropharynx of the i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace
Comparison of the insertion success in the oropharynx of i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace
Measured: From insertion of supraglottic between the lips of the subject to final success or failure of insertion 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jun 2022 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS GAITINI MD, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951089
- Sponsor's protocol ID
- 0087-21-BNZ
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Performances of Air-Q SP 3G and i-Gel by Novice Intubators During Manual In-line Neck Stabilization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04951089
- Acronym / sponsor ID
- 0087-21-BNZ
- Conditions
- Anesthesia
- Keywords
- Supraglottic devices, Airway, Insertion success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 6 Jul 2021 (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.
Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal. The Advance Trauma Life Support suggested the use of Supraglottic Airway Devise (SAD) in managing the difficult airway. The air-Q SP 3G was introduced as an alternative for managing the difficult airway. The i-gel is proposed as supraglottic device made of a medical grade thermoplastic elastomer. The unique design of both devices is that a cuff is not needed to be inflated .
A randomize controlled trail will be conduce. Participants will insert the both supraglottic devices to compare performance of ventilation and oxygenation of the patients.
The insertion will be performed on age 18-75 year patients, scheduled for elective surgery with general anesthesia. The SAD use in the study will be a single use i-gel size 4 or 5 and the air-Q SP 3G- size 4 or 5 For induction of anesthesia all patients will receive premedication. After 3 min of preoxygenation anesthesia will induce with up to 2 mcg/Kg fentanyl and 2-3 mg propofol Neuromuscular blockade will be obtained with rocuronion.
The participant will performed one insertion of the i-gel or the air-Q SP 3G on the patient while manual in-line stabilization of the neck Primary outcome: time to success insertion of SAD Secondary outcome : duration in seconds of insertion
Detailed description
In the combat setting, airway compromise is the second leading cause of preventable death after hemorrhage.
Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal.
Possible reasons for the failure in achieving definitive airway in trauma patients are the requirement for in-line stabilization of the neck, and the inexperience of the providers.
The Tactical Combat Casualty Care (TCCC) Guidelines recommend using a supraglottic airway device (SAD) as an option to assist in securing the airway in tactical evacuation phase of care.
In a recent published Randomized Control Trail in patients, the success of blind intubation did not support the use of tracheal intubation (TI) via iLTS-D by novice intubators. However, this study revealed a high success rate (84.6%) of iLTS-D placement in the oropharynx, associated with effective ventilation as confirmed by capnography.
The time to obtain successful iLTS-D placement in the oropharynx was 42 sec, which is 2.5 times shorter than the time to achieve TI with DL.
These results encourage the use of a second generation Supraglottic Airway Device (SAD) by novice intubators as the first airway intervention in trauma patients, who require immediate airway management.
SADs play a key role as primary and rescue devices in predicted and unanticipated difficult airway management, by providing both a patent airway for oxygenation and ventilation and a conduit for TI, thereby avoiding the disastrous outcomes of 'cannot intubate, cannot oxygenate' situations.
Recently study reported the effectiveness of initial insertion with Laryngeal Tube (LT) vs initial Endotracheal Intubation (ETI) in adults out of Hospital cardiac arrest (OHCA).This study concludes that a strategy of initial LT insertion was associated with significantly greater 72-hour survival compare with the strategy of initial ETI.
These findings suggest that SAD insertion may be considered as an initial airway management strategy in patients with OHCA.
The implication of the SAD effectivity in fasting rescue the airway pattern and reassure oxygenation is greatest importance in combat setting.
The self-pressurized air-Q intubating laryngeal airway (air-Q SP 3G) (Mercury Medical, Clearwater, FL, USA) is a single-use SAD that does not require cuff inflation. The original air-Q intubating laryngeal airway (Cookgas LLC; Mercury Medical) was designed to facilitate tracheal intubation through its lumen.
The air-Q SP 3G differs from the original air-Q by the absence of an inflatable cuff and the continuity between the airway tube and cuff through an inner aperture at the junction the airway tube and periglottic cuff of the air-Q SP 3G makes the intracuff pressure equilibrate dynamically with the airway pressure and is designed to adjust to the patient's pharyngeal and periglottic anatomy .
The absence of a pilot balloon and continuity between the airway tube and the cuff through an inner aperture has several clinical benefits when compared with other cuffed SAD.
First, the provider does not loose time with the inflation cuff maneuver. Second, intra-cuff pressures are determined by the airway pressures, because of the equalization of pressures with the movement of gas between the cuff and airway tube.
Third, lower intra-cuff pressures are maintained overall as a result of being limited by the peak airway pressures, with the highest pressures exerted during inspiration. Fourth, by not exceeding peak airway pressures, the balance between intra-cuff pressures and the airway seal of the device may be optimized at lower pressure. Therefore, the risk of sore throat, neuropraxic injury, and gastric insufflation seen with overinflation of traditional cuffed supraglottic devices may be reduced.
Recently, the air-Q SP 3G has been upgraded with the addition of the gastric channel in order diminish the risk of aspiration.
The i-gel second generation SAD, disposable airway (Intersurgical Ltd, Workingham, UK) is a SAD made of a medical grade thermoplastic elastomer. Its unique design does not need an inflatable cuff because the thermoplastic elastomer provides the seal. The i-gel is gaining a reputation for its ease of insertion and for its use in many clinical situations. Previous studies have demonstrated that the i-gel can be placed more faster than conventional laryngeal mask airways, which might play a role in prehospital settings. Other advantages of the i-gel are ease of training, cost, safety, and simplicity of use.
There have been no studies comparing these devices in patients with limited neck extension. Therefore, the aim is to compare the clinical performance of these two devices in adult patients with simulated cervical immobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel supraglottic device insertion for oxygenation | Experimental | Device: i-gel Supraglottic device insertioni-gel supraglottic device insertion for oxygenation i-gel supraglottic device insertion for oxygenation and ventilation |
| Air-Q SP 3G supraglottic insertion for oxygenation | Experimental | Device: Air-Q SP 3G Supraglottic device insertionAir-Q SP 3G supraglottic device insertion for oxygenation Air-Q SP 3G supraglottic device insertion for oxygenation and ventilation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient ASA ( American Society Anesthesiologist) I-II
- non pregnancy
Key exclusion criteria (2 listed)
- Difficult airway
- pregnancy
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 |
|---|---|---|
| i-gel Supraglottic device insertioni-gel insertion for oxygenation | Device | i-gel supraglottic device insertion for oxygenation |
| Air-Q SP 3G Supraglottic device insertionAir-Q SP 3G insertion for oxygenation | Device | Air-Q SP 3G supraglottic insertion for oxygenation |
Primary outcome
Insertion success ratio between supraglottic device the i-gel and Air-Q SP 3G Comparison of the insertion success in the oropharynx of the i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace
Time frame: From insertion of supraglottic between the lips of the subject to final success or failure of insertion 30 seconds
Comparison of the insertion success in the oropharynx of i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel Supraglottic device insertion and Air-Q SP 3G Supraglottic device insertion in people with Anesthesia, run by Bnai Zion Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. 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?
Results are not available in the source record.
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?
Insertion success ratio between supraglottic device the i-gel and Air-Q SP 3G Comparison of the insertion success in the oropharynx of the i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace (time frame: From insertion of supraglottic between the lips of the subject to final success or failure of insertion 30 seconds). 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 15 Apr 2022.