Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

Intubation Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550978
• Other study ID #: HST-AG-04
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: February 17, 2016
• Start date: February 2012
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Hospitech Respiration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intubation Complications

Intervention

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.

Locations

Country	Name	City	State
Italy	Policlinico Universitario A. Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Hospitech Respiration

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes