Working... Menu

Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

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. Identifier: NCT01550978
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Hospitech Respiration

Brief 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.

Condition or disease Intervention/treatment Phase
Intubation Complications Device: AnapnoGuard 100 System Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Arm Intervention/treatment
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

Primary Outcome Measures :
  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) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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)

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 identifier (NCT number): NCT01550978

Layout table for location information
Policlinico Universitario A. Gemelli
Rome, Italy
Sponsors and Collaborators
Hospitech Respiration
Layout table for investigator information
Principal Investigator: Massimo Antonelli, Prof. Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hospitech Respiration Identifier: NCT01550978     History of Changes
Other Study ID Numbers: HST-AG-04
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016