Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube

August 24, 2015 updated by: Antonio Pesenti, Azienda Ospedaliera San Gerardo di Monza

Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial

Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 23900
        • Azienda Ospedaliera San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to an ICU
  • 18 years old or more
  • expected to be intubated for more than 48 hours
  • less than 24 hours from intubation
  • fraction of inspired oxygen set at the ventilator <80%

Exclusion Criteria:

  • Current or past participation in another intervention trial conflicting with the present study
  • expected survival less than 24 hours
  • Acute severe asthma
  • Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO
  • Double lumen endotracheal tube in place
  • Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)
  • other contraindications posed by staff physicians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Airway Medix Closed Suction System
Device: Airway medix closed suction system
Active Comparator: control
standard closed suctioning systems
Device: standard closed suctioning systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of secretions
Time Frame: within 12 hours after extubation
Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan
within 12 hours after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: until extubation, death or tracheostomy (approximately 2 weeks)
report of major and minor adverse events related to the use of the device
until extubation, death or tracheostomy (approximately 2 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
endotracheal tube colonization
Time Frame: within 48 hours after extubation
assessed by microbiologic testing of the endotracheal tube lavage fluid
within 48 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Gerardo di Monza

Investigators

  • Principal Investigator: Antonio Pesenti, MD, San Gerardo Hospital
  • Study Director: Giacomo Bellani, MD PhD, San Gerardo Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 180-20130326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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