Back to resultsOptimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
AnapnoGuard 100
Sponsored by
About this trial
This is an interventional supportive care trial for Ventilator Associated Pneumonia focused on measuring VAP
Eligibility Criteria
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.
Sites / Locations
- Spitalu Universitar De Urgente Elias Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AnapnoGuard
Arm Description
Outcomes
Primary Outcome Measures
Recording the changes in optimal ETT cuff pressure and their effectors during the course of mechanical ventilation and intubation in Intensive Care Unit (ICU).
Secondary Outcome Measures
Adverse events occurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01188122
Brief Title
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Official Title
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospitech Respiration
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
VAP
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AnapnoGuard
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AnapnoGuard 100
Intervention Description
Respiratory guard system during mechanical ventilation
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Adverse events occurrence
Time Frame
During intubation (2-14 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Popescu, Dr.
Organizational Affiliation
Spitalu Universitar De Urgenta Elias Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spitalu Universitar De Urgente Elias Hospital
City
Bukarest
Country
Romania
12. IPD Sharing Statement
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Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
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