NCT01547507UnknownNot Applicable
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System
Biovo Technologies Ltd1 site in 1 country26 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- hemodynamic and respiratory data
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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 -
Outcomes
Primary Outcomes
hemodynamic and respiratory data
Time Frame: Patients will be followed until extubation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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