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Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

NCT01550978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-02-19

No results posted yet for this study

Summary

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.

Conditions

  • Intubation Complications

Interventions

DEVICE

AnapnoGuard 100 System

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.

Sponsors & Collaborators

  • Hospitech Respiration

    lead INDUSTRY

Principal Investigators

  • Massimo Antonelli, Prof. · Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Italy

Study Locations

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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 NCT01550978 on ClinicalTrials.gov