Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

NCT01550978 | Completed

• 1 other identifier: HST-AG-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complications

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Study Group

EXPERIMENTAL

Patients intubated with AnapnoGuard EndoTracheal Tube and connected to the AnapnoGuard 100 Control System

Device: AnapnoGuard 100 System

Control Group

NO INTERVENTION

Patients intubated with the Standard of Care EndoTracheal Tube and Connected to a Suction Regulator

Interventions

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.

Study Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospitech Respiration: lead

Study Sites (1)

Policlinico Universitario A. Gemelli

Rome, Italy

Location

Related Publications (1)

• 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.

  PMID: 28493877 DERIVED

Study Officials

• Massimo Antonelli, Prof.

  Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 12, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

IT (1)