Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

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

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.

Study Overview

• Status: Completed
• Conditions: Intubation Complications
• Intervention / Treatment: Device: AnapnoGuard 100 System

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Policlinico Universitario A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of AE (adverse events) and SAE (serious adverse events)	participants will be followed for the entire duration of intubation (an expected average of 8 days)

Collaborators and Investigators

• Sponsor: Hospitech Respiration
• Investigators: Principal Investigator: Massimo Antonelli, Prof., Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli

Publications and helpful links

General Publications

• De Pascale G, Pennisi MA, Vallecoccia MS, Bello G, Maviglia R, Montini L, Di Gravio V, Cutuli SL, Conti G, Antonelli M. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study. PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HST-AG-04