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Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

Recruiting
18 years and older
All
Phase N/A

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Overview

The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie

Eligibility

Inclusion Criteria:

  • elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Exclusion Criteria:

  • pregnancy
  • known or suspected difficult airway management
  • history of oropharyngeal or upper airway surgery
  • known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
  • BMI greater than 40 kg/m2
  • unable to undergo intubation via the oral route
  • known or suspected full stomach or other risk factors for aspiration
  • contraindication for the use of neuromuscular blocking agents
  • history of significant gastroesophageal reflux disease (GERD)
  • Vulnerable populations (cognitively impaired persons, prisoners)

Study details
    Anesthesia

NCT05989880

The University of Texas Health Science Center, Houston

19 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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