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NCT01547507 Clinical Trial

Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Mechanical Ventilation Clinical Trial

Official title:
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01547507
Other study ID # Biovo-12-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received February 22, 2012
Last updated May 29, 2012
Start date March 2012

Study information
Verified date May 2012
Source Biovo Technologies Ltd
Contact Nimrod Adi, MD
Email Nimrodad@clalit.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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:

1. AirWay Medix Closed Suction System

2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).

Recruitment information / eligibility
Status Recruiting
Enrollment 26
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Aged greater than 18 years

2. Mechanically ventilated for more than 6 hours

3. Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment

4. Signed informed consent

5. Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -

Exclusion Criteria:

1. Gross / massive hemoptysis

2. Received lung transplantation in the past

3. Admitted from other hospital already mechanically ventilated

4. Previously received mechanical ventilation

5. Active bronchial bleeding

6. Pregnant women, women who plan to become pregnant and breastfeeding women.

7. Substance or alcohol abuse

8. Participation in concurrent trials

9. Any reasons making the patient a poor candidate in the opinion of the investigator -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• AirWay Medix Closed Suction System
AirWay Medix Closed Suction System

Locations
Country Name City State
Israel Kaplaan MC Rehovot

Sponsors (1)
Lead Sponsor Collaborator
Biovo Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary hemodynamic and respiratory data Patients will be followed until extubation No
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