NCT01547507

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

February 22, 2012

Last Update Submit

May 29, 2012

Conditions

Endotracheal TubeMechanical Ventilation

Keywords

hemodynamicsrespiratory

Outcome Measures

Primary Outcomes (1)

  • hemodynamic and respiratory data

    Patients will be followed until extubation

Study Arms (2)

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

AirWay Medix Closed Suction SystemDEVICE

AirWay Medix Closed Suction System

Airway Medix Closed Suction SystemKimVent Turbo-Cleaning Closed Suction System Kimberly clark

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplaan MC

Rehovot, Israel

RECRUITING

Study Officials

  • Nimrod Adi, MD

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimrod Adi, MD

CONTACT

Nimrodad@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

IL(1)