Performance Evaluation of AirWay Medix Closed Suction Sys... | NCT01547507

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

NCT01547507

Sponsor

Biovo Technologies Ltd

Status

Unknown status

Last Update Posted

May 30, 2012Estimated

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Endotracheal Tube
Mechanical Ventilation

Interventions

AirWay Medix Closed Suction System

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2012

Last Update Posted Date

May 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KimVent Turbo-Cleaning Closed Suction System Kimberly clark	Active Comparator		Device: AirWay Medix Closed Suction System
Airway Medix Closed Suction System	Active Comparator		Device: AirWay Medix Closed Suction System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AirWay Medix Closed Suction System	Device	AirWay Medix Closed Suction System	Airway Medix Closed Suction System KimVent Turbo-Cleaning Closed Suction System Kimberly clark

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nimrod Adi, MD	Contact			Nimrodad@clalit.org.il

Overall Officials

Name	Affiliation	Role
Nimrod Adi, MD	Kaplan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaplaan MC	Recruiting	Rehovot			Israel