Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

Hospitech Respiration60 enrolled

Overview

The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Intubation Complications

Interventions

AnapnoGuard 100 SystemDEVICE

AnapnoGuard™ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age above 21 (men and women); * Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours * Absence of clear signs of pneumonia and lung contusion on chest X ray; * For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation; * No fever or fever from a known non chest/lung origin; Exclusion Criteria: * Patients who had been treated with mechanical ventilation during the last 3 months; * Patients with facial, oropharyngeal or neck trauma * BMI \> 40 * Pregnant women * Patients ventilated in prone position * Difficult intubation (defined as more than 3 intubation attempts)

Locations (1)

Policlinico Universitario A. Gemelli

Rome, Italy

Outcomes

Primary Outcomes

Rate of AE (adverse events) and SAE (serious adverse events)

Time frame: participants will be followed for the entire duration of intubation (an expected average of 8 days)

Data from ClinicalTrials.gov

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