Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-09-30

Brief Summary

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Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically ventilated patients. Optimal ETT cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure.

This study was design in order to evaluate the feasibility of using the AnapnoGuard system.

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Detailed Description

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Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AnapnoGuard

Group Type EXPERIMENTAL

AnapnoGuard 100

Intervention Type DEVICE

Respiratory guard system during mechanical ventilation

Interventions

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AnapnoGuard 100

Respiratory guard system during mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age above 18 (men and woman);
* Patient is admitted to ICU and expected to receive mechanical ventilation for at least 48 hours;
* Normal chest X-ray;
* Connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
* Signed informed consent by subject's legally acceptable representative.

Exclusion Criteria

* Patients who had been treated with mechanical ventilation during the last year;
* Fever from known chest/lung origin;
* Patients with facial, oropharyngeal or neck trauma;
* BMI\>35;
* Height \< 1.6 m;
* Any chest X-ray pathology during the first 24 hours post intubation;
* More than 7 days hospitalization prior to the intubation. Chest/lung infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No