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

This study is currently recruiting participants.
Verified May 2012 by Biovo Technologies Ltd
Sponsor:
Information provided by (Responsible Party):
Biovo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT01547507
First received: February 22, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention
Endotracheal Tube
Mechanical Ventilation
Device: AirWay Medix Closed Suction System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Further study details as provided by Biovo Technologies Ltd:

Primary Outcome Measures:
  • hemodynamic and respiratory data [ Time Frame: Patients will be followed until extubation ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Biovo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01547507     History of Changes
Other Study ID Numbers: Biovo-12-CTIL
Study First Received: February 22, 2012
Last Updated: May 29, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Biovo Technologies Ltd:
hemodynamics
respiratory

ClinicalTrials.gov processed this record on April 16, 2014