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

NCT04909944 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-06-02

No results posted yet for this study

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

Interventions

DEVICE

i-gel Supraglottic insertion

i-gel Supraglottic insertion for oxygenation

DEVICE

Laryngeal Tube Suction Disposable Supraglottic insertion

Laryngeal Tube Suction Disposable Supraglottic insertion for oxygenation

Sponsors & Collaborators

  • Bnai Zion Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-08-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909944 on ClinicalTrials.gov