Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

This study is currently recruiting participants.
Verified November 2013 by Hospitech Respiration
Sponsor:
Information provided by (Responsible Party):
Hospitech Respiration
ClinicalTrials.gov Identifier:
NCT01550978
First received: February 21, 2012
Last updated: November 10, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01550978

Contacts
Contact: Yoav Venkert, Mr. +972 3 919 1648 Yoav@hospitech.co.il

Locations
Italy
Policlinico Universitario A. Gemelli Recruiting
Rome, Italy
Contact: Gennaro De Pascale, Dr.    +39 320 899 8173    gennaro.depascale@edu.rm.unicatt.it   
Principal Investigator: Massimo Antonelli, Prof.         
Sub-Investigator: Gennaro De Pascale, Dr.         
Sub-Investigator: Mariano Pennisi, Dr.         
Sponsors and Collaborators
Hospitech Respiration
Investigators
Principal Investigator: Massimo Antonelli, Prof. Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli
  More Information

No publications provided

Responsible Party: Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01550978     History of Changes
Other Study ID Numbers: HST-AG-04
Study First Received: February 21, 2012
Last Updated: November 10, 2013
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014