- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547507
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nimrod Adi, MD
- Email: Nimrodad@clalit.org.il
Study Locations
-
-
-
Rehovot, Israel
- Recruiting
- Kaplaan MC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: KimVent Turbo-Cleaning Closed Suction System Kimberly clark
|
AirWay Medix Closed Suction System
|
Active Comparator: Airway Medix Closed Suction System
|
AirWay Medix Closed Suction System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hemodynamic and respiratory data
Time Frame: Patients will be followed until extubation
|
Patients will be followed until extubation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nimrod Adi, MD, Kaplan Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Biovo-12-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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