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

NCT ID: NCT01547507

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Endotracheal Tube Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KimVent Turbo-Cleaning Closed Suction System Kimberly clark

Group Type ACTIVE_COMPARATOR

AirWay Medix Closed Suction System

Intervention Type DEVICE

AirWay Medix Closed Suction System

Airway Medix Closed Suction System

Group Type ACTIVE_COMPARATOR

AirWay Medix Closed Suction System

Intervention Type DEVICE

AirWay Medix Closed Suction System

Interventions

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AirWay Medix Closed Suction System

AirWay Medix Closed Suction System

Intervention Type DEVICE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biovo Technologies Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nimrod Adi, MD

Role: PRINCIPAL_INVESTIGATOR

Kaplan Medical Center

Locations

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Kaplaan MC

Rehovot, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nimrod Adi, MD

Role: CONTACT

Other Identifiers

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Biovo-12-CTIL

Identifier Type: -

Identifier Source: org_study_id

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