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

History of Changes

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:

AirWay Medix Closed Suction System
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:

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

Exclusion Criteria:

Gross / massive hemoptysis
Received lung transplantation in the past
Admitted from other hospital already mechanically ventilated
Previously received mechanical ventilation
Active bronchial bleeding
Pregnant women, women who plan to become pregnant and breastfeeding women.
Substance or alcohol abuse
Participation in concurrent trials
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 May 21, 2013

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