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

A

Azienda Ospedaliera San Gerardo di Monza

Status and phase

Completed
Phase 2

Conditions

Intubation
Expected Duration of Ventilation > 48h

Treatments

Device: standard closed suctioning systems
Device: Airway medix closed suction system

Study type

Interventional

Funder types

Other

Identifiers

NCT01912105
180-20130326

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

treatment
Experimental group
Description:
Airway Medix Closed Suction System
Treatment:
Device: Airway medix closed suction system
control
Active Comparator group
Description:
standard closed suctioning systems
Treatment:
Device: standard closed suctioning systems

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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