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

Not Applicable

• Conditions: Endotracheal Tube; Mechanical Ventilation
• Interventions: Device: AirWay Medix Closed Suction System

• Registration Number: NCT01547507
• Lead Sponsor: Biovo Technologies Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-22
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KimVent Turbo-Cleaning Closed Suction System Kimberly clark	AirWay Medix Closed Suction System	-
Airway Medix Closed Suction System	AirWay Medix Closed Suction System	-

Primary Outcome Measures

Name	Time	Method
hemodynamic and respiratory data	Patients will be followed until extubation

Trial Locations

Locations (1)

Kaplaan MC; 🇮🇱 Rehovot, Israel