Comparison of the Clinical Performances of Air-Q SP 3G and i-Gel

NCT04951089 | Unknown

• 1 other identifier: 0087-21-BNZ
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Anesthesia

Keywords

Supraglottic devices; Airway; Insertion success

Outcome Measures

Primary Outcomes (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

  From insertion of supraglottic between the lips of the subject to final success or failure of insertion 30 seconds

Study Arms (2)

i-gel supraglottic device insertion for oxygenation

EXPERIMENTAL

i-gel supraglottic device insertion for oxygenation i-gel supraglottic device insertion for oxygenation and ventilation

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

Device: Air-Q SP 3G Supraglottic device insertion

Interventions

i-gel Supraglottic device insertion DEVICE

i-gel insertion for oxygenation

i-gel supraglottic device insertion for oxygenation

Air-Q SP 3G Supraglottic device insertion DEVICE

Air-Q SP 3G insertion for oxygenation

Air-Q SP 3G supraglottic insertion for oxygenation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ASA ( American Society Anesthesiologist) I-II
• non pregnancy

You may not qualify if:

• Difficult airway
• pregnancy

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Prpfessor of Anesthesiology

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: June 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: October 31, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04