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Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

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ClinicalTrials.gov Identifier: NCT01547507
Recruitment Status : Unknown
Verified May 2012 by Biovo Technologies Ltd.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):
Biovo Technologies Ltd

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:

  1. AirWay Medix Closed Suction System
  2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).

Condition or disease Intervention/treatment Phase
Endotracheal Tube Mechanical Ventilation Device: AirWay Medix Closed Suction System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
Study Start Date : March 2012
Estimated Primary Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: KimVent Turbo-Cleaning Closed Suction System Kimberly clark Device: AirWay Medix Closed Suction System
AirWay Medix Closed Suction System
Active Comparator: Airway Medix Closed Suction System Device: AirWay Medix Closed Suction System
AirWay Medix Closed Suction System


Outcome Measures
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Primary Outcome Measures :
  1. hemodynamic and respiratory data [ Time Frame: Patients will be followed until extubation ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged greater than 18 years
  2. Mechanically ventilated for more than 6 hours
  3. Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
  4. Signed informed consent
  5. Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -

Exclusion Criteria:

  1. Gross / massive hemoptysis
  2. Received lung transplantation in the past
  3. Admitted from other hospital already mechanically ventilated
  4. Previously received mechanical ventilation
  5. Active bronchial bleeding
  6. Pregnant women, women who plan to become pregnant and breastfeeding women.
  7. Substance or alcohol abuse
  8. Participation in concurrent trials
  9. Any reasons making the patient a poor candidate in the opinion of the investigator -
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01547507


Contacts
Contact: Nimrod Adi, MD Nimrodad@clalit.org.il

Locations
Israel
Kaplaan MC Recruiting
Rehovot, Israel
Sponsors and Collaborators
Biovo Technologies Ltd
Investigators
Principal Investigator: Nimrod Adi, MD Kaplan Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Biovo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01547507     History of Changes
Other Study ID Numbers: Biovo-12-CTIL
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Biovo Technologies Ltd:
hemodynamics
respiratory