Skip to main content
OpenTrials
Completed

NCT Number: NCT01550978

Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intubation Complications

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario A. Gemelli

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AnapnoGuard 100 System

Device

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.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hospitech Respiration

Industry

Registry information

Official study title

The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2012
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.