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

August 23, 2010 updated by: Hospitech Respiration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bukarest, Romania
        • Spitalu Universitar De Urgente Elias Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AnapnoGuard
Device: AnapnoGuard 100
Respiratory guard system during mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
during intubation (2-14 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events occurrence
Time Frame: During intubation (2-14 days)
During intubation (2-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitech Respiration

Investigators

  • Principal Investigator: Marian Popescu, Dr., Spitalu Universitar De Urgenta Elias Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HST -AG -01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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