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

NCT01188122 | Completed

• 1 other identifier: HST -AG -01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Keywords

VAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events occurrence

  During intubation (2-14 days)

Study Arms (1)

AnapnoGuard

EXPERIMENTAL

Device: AnapnoGuard 100

Interventions

AnapnoGuard 100 DEVICE

Respiratory guard system during mechanical ventilation

AnapnoGuard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospitech Respiration: lead

Study Sites (1)

Spitalu Universitar De Urgente Elias Hospital

Bucharest, Romania

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Officials

• Marian Popescu, Dr.

  Spitalu Universitar De Urgenta Elias Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: April 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

RO (1)