Performance of the I-gel and the Laryngeal Tube Suction Disposable by Novice Intubators"

NCT04909944 | Unknown

• 1 other identifier: 0069-21-BNZ
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Establishing a definitive airway is 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 Studies revealed that the success rate of tracheal intubation in the prehospital setting is suboptimal. The Advance Trauma Life Support suggested the use of the Supraglottic Airway Devices in managing patients who require an advanced airway adjunct, but in whom intubation has failed. The Laryngeal Tube Suction Disposable (LTS-D), was introduced as an alternative for managing the difficult airway, initially intended for routine clinical use. Within recent years, laryngeal tubes have also been reported to be successfully used in emergency airway management. The i-gel disposable airway is proposed as a new supraglottic airway device (SAD) made of a medical grade thermoplastic elastomer. Its unique design does not need an inflatable cuff. A randomized controlled trail will be conducted. Participants will insert the both supraglottic airway devices to compare performance of ventilation and oxygenation of the patients. The insertion will be performed on aged 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, an size 5 and the LTS-D size 4 and the size 5. For induction of anesthesia, all patients will receive premedication with oral diazepam (10 mg). After 3 min of preoxygenation with an inspired oxygen fraction of 100%, anesthesia will be induced with up to 3mcg/kg fentanyl and 2-3 mg/kg propofol and will be maintained with 70% nitrous oxide/30% oxygen and sevoflurane. Neuromuscular blockade will be obtained with rocuronium. After complete neuromuscular blockade, the study procedure will be initiated. The participant will perform one insertion of i-gel or the LTS-D on the patient while manual in-line stabilization of the neck. Primary outcome measure - insertion success rate. The primary outcome measure will be success rate of effective insertion of the Supraglottic Airway Devices in the patients with registration of the CO2 (carbon di oxide) curve. Secondary outcome measure - duration in seconds of the insertion. The duration of the Supraglottic Airway Devices insertion will be defined as the duration time, in seconds, from insertion of the Supraglottic Airway Devices in the lips of the patient until will be correctly positioned in the trachea by the participant.

Conditions

Anesthesia

Keywords

Supraglottic devices; Airway; Insertion success

Outcome Measures

Primary Outcomes (1)

• Insertion success ratio between supraglottic devices the laryngeal tube suction disposable and the i-gel

  Comparison of the insertion success in the oropharynx of laryngeal tube suction disposable and the i-gel supraglottic devices, insertion success detected by capnography trace

  30 seconds

Study Arms (2)

i-gel supraglottic device insertion for oxygenation

EXPERIMENTAL

i-gel supraglottic device insertion for oxygenation and ventilation

Device: i-gel Supraglottic insertion

laryngeal tube suction disposable supraglottic insertion for oxygenation

EXPERIMENTAL

laryngeal tube suction disposable insertion for oxygenation and ventilation

Device: Laryngeal Tube Suction Disposable Supraglottic insertion

Interventions

i-gel Supraglottic insertion DEVICE

i-gel Supraglottic insertion for oxygenation

i-gel supraglottic device insertion for oxygenation

Laryngeal Tube Suction Disposable Supraglottic insertion DEVICE

Laryngeal Tube Suction Disposable Supraglottic insertion for oxygenation

laryngeal tube suction disposable 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 Anesthesiologists) guidelines 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 Professor of Anesthesiology

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: July 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 31, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-06