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

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia
• Interventions: Device: AnapnoGuard 100

• Registration Number: NCT01188122
• Lead Sponsor: Hospitech Respiration

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Last Update Submitted: 2010-08-23
• Study First Posted: 2010-08-25
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AnapnoGuard	AnapnoGuard 100	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Adverse events occurrence	During intubation (2-14 days)

Trial Locations

Locations (1)

Spitalu Universitar De Urgente Elias Hospital; 🇷🇴 Bukarest, Romania