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Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Biovo Technologies Ltd.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Biovo Technologies Ltd
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
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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 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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01547507
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
| 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 |
Keywords provided by Biovo Technologies Ltd:
|
hemodynamics respiratory |
ClinicalTrials.gov processed this record on June 26, 2017