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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01547507

Enrollment

Registered

2012-03-08

Start date

2012-03-31

Completion date

Unknown

Last updated

2012-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube, Mechanical Ventilation

Keywords

hemodynamics, respiratory

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: 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).

Interventions

DEVICEAirWay Medix Closed Suction System

AirWay Medix Closed Suction System

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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 -

Design outcomes

Primary

Measure	Time frame
hemodynamic and respiratory data	Patients will be followed until extubation

Countries

Israel

Contacts

Primary ContactNimrod Adi, MD

Nimrodad@clalit.org.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026