Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System

Hospitech Respiration

Status: Completed

Conditions: Intubation Complications

Treatments: Device: AnapnoGuard 100 System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01550978

HST-AG-04

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Study Group

Experimental group

Description:

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

Treatment:

Device: AnapnoGuard 100 System

Control Group

No Intervention group

Description:

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