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

NCT ID: NCT01912105

Last Updated: 2015-08-25

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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Conditions

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Intubation Expected Duration of Ventilation > 48h

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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treatment

Airway Medix Closed Suction System

Group Type EXPERIMENTAL

Airway medix closed suction system

Intervention Type DEVICE

control

standard closed suctioning systems

Group Type ACTIVE_COMPARATOR

standard closed suctioning systems

Intervention Type DEVICE

Interventions

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Airway medix closed suction system

Intervention Type DEVICE

standard closed suctioning systems

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role lead

Responsible Party

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Antonio Pesenti

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Pesenti, MD

Role: PRINCIPAL_INVESTIGATOR

San Gerardo Hospital

Giacomo Bellani, MD PhD

Role: STUDY_DIRECTOR

San Gerardo Hospital

Locations

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Azienda Ospedaliera San Gerardo

Monza, , Italy

Site Status

Countries

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Italy

References

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Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.

Reference Type BACKGROUND
PMID: 21926595 (View on PubMed)

Coppadoro A, Bellani G, Bronco A, Lucchini A, Bramati S, Zambelli V, Marcolin R, Pesenti A. The use of a novel cleaning closed suction system reduces the volume of secretions within the endotracheal tube as assessed by micro-computed tomography: a randomized clinical trial. Ann Intensive Care. 2015 Dec;5(1):57. doi: 10.1186/s13613-015-0101-9. Epub 2015 Dec 30.

Reference Type DERIVED
PMID: 26714807 (View on PubMed)

Other Identifiers

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180-20130326

Identifier Type: -

Identifier Source: org_study_id

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