Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

NCT ID: NCT01550978

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study Group

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

Group Type: EXPERIMENTAL

AnapnoGuard 100 System

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospitech Respiration

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Massimo Antonelli, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Policlinico Universitario A. Gemelli

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28493877 (View on PubMed)

Other Identifiers

HST-AG-04

Identifier Type: -

Identifier Source: org_study_id