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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188122
• Other study ID #: HST -AG -01
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: August 23, 2010
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2010
• Source: Hospitech Respiration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Device:
• AnapnoGuard 100
Respiratory guard system during mechanical ventilation

Locations

Country	Name	City	State
Romania	Spitalu Universitar De Urgente Elias Hospital	Bukarest

Sponsors (1)

Lead Sponsor	Collaborator
Hospitech Respiration

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).		during intubation (2-14 days)	No
Secondary	Adverse events occurrence		During intubation (2-14 days)	Yes