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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 groups in NCT04951089
Study groupRoleWhat they receive
i-gel supraglottic device insertion for oxygenationExperimentali-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 oxygenationExperimentalAir-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.

  1. 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.

  1. First posted6 Jul 2021
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion30 Jul 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

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)
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

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.

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