Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction 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: 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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Endotracheal Tube Mechanical Ventilation | Device: AirWay Medix Closed Suction System | Not Applicable |
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 |
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
|
- hemodynamic and respiratory data [ Time Frame: Patients will be followed until extubation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 -

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
Contact: Nimrod Adi, MD | Nimrodad@clalit.org.il |
Israel | |
Kaplaan MC | Recruiting |
Rehovot, Israel |
Principal Investigator: | Nimrod Adi, MD | Kaplan Medical Center |
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 |