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

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.

Completed

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spitalu Universitar De Urgente Elias Hospital

Bucharest, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AnapnoGuard 100

Device

Respiratory guard system during mechanical ventilation

Primary outcomes

Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).

Time frame: during intubation (2-14 days)

Secondary outcomes

Adverse events occurrence

Time frame: During intubation (2-14 days)

Sponsors and collaborators

Lead sponsor

Hospitech Respiration

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Aug 25, 2010
Registry last updated: Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed