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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188122
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Ventilator Associated Pneumonia Device: AnapnoGuard 100 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Study Start Date : April 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: AnapnoGuard Device: AnapnoGuard 100
Respiratory guard system during mechanical ventilation




Primary Outcome Measures :
  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). [ Time Frame: during intubation (2-14 days) ]

Secondary Outcome Measures :
  1. Adverse events occurrence [ Time Frame: During intubation (2-14 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188122


Locations
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Romania
Spitalu Universitar De Urgente Elias Hospital
Bukarest, Romania
Sponsors and Collaborators
Hospitech Respiration
Investigators
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Principal Investigator: Marian Popescu, Dr. Spitalu Universitar De Urgenta Elias Hospital

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Responsible Party: Study Director, Hospitech Respiration
ClinicalTrials.gov Identifier: NCT01188122    
Other Study ID Numbers: HST -AG -01
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: August 2010
Keywords provided by Hospitech Respiration:
VAP
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection