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

Biovo Technologies

Status: Unknown

Conditions: Endotracheal Tube; Mechanical Ventilation

Treatments: Device: AirWay Medix Closed Suction System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547507

Biovo-12-CTIL

Details and patient eligibility

About

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).

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

KimVent Turbo-Cleaning Closed Suction System Kimberly clark

Active Comparator group

Treatment:

Device: AirWay Medix Closed Suction System

Airway Medix Closed Suction System

Active Comparator group

Treatment:

Device: AirWay Medix Closed Suction System