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Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 12, 2012
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospitech Respiration
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.

Condition Intervention
Intubation Complications Device: AnapnoGuard 100 System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients

Resource links provided by NLM:

Further study details as provided by Hospitech Respiration:

Primary Outcome Measures:
  • 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) ]

Enrollment: 60
Study Start Date: February 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Patients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System
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.
No Intervention: Control Group
Patients intubated with the Standard of Care EndoTracheal Tube and Connected to a Suction Regulator


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550978

Policlinico Universitario A. Gemelli
Rome, Italy
Sponsors and Collaborators
Hospitech Respiration
Principal Investigator: Massimo Antonelli, Prof. Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli
  More Information

Responsible Party: Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01550978     History of Changes
Other Study ID Numbers: HST-AG-04
First Submitted: February 21, 2012
First Posted: March 12, 2012
Last Update Posted: February 19, 2016
Last Verified: February 2016