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OpenTrials
Completed

NCT Number: NCT01912105

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

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

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Key information

Conditions

Intubation Expected Duration of Ventilation > 48h

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedaliera San Gerardo

Monza, 23900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airway medix closed suction system

Device

standard closed suctioning systems

Device

Primary outcomes

  1. Volume of secretions

    Time frame: within 12 hours after extubation

    Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan

Secondary outcomes

  1. 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

Other outcomes

  1. endotracheal tube colonization

    Time frame: within 48 hours after extubation

    assessed by microbiologic testing of the endotracheal tube lavage fluid

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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