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

NCT01912105 | Completed Phase 2

• 1 other identifier: 180-20130326
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation; Expected Duration of Ventilation > 48h

Keywords

endotracheal tube; ct scan; cleaning device; biofilm; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Volume of secretions

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

  within 12 hours after extubation

Secondary Outcomes (1)

• adverse events

  until extubation, death or tracheostomy (approximately 2 weeks)

Other Outcomes (1)

• endotracheal tube colonization

  within 48 hours after extubation

Study Arms (2)

treatment

EXPERIMENTAL

Airway Medix Closed Suction System

Device: Airway medix closed suction system

control

ACTIVE COMPARATOR

standard closed suctioning systems

Device: standard closed suctioning systems

Interventions

Airway medix closed suction system DEVICE

treatment

standard closed suctioning systems DEVICE

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to an ICU
• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera San Gerardo di Monza: lead

Study Sites (1)

Azienda Ospedaliera San Gerardo

Monza, 23900, Italy

Location

Related Publications (2)

• 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.

  PMID: 21926595 BACKGROUND

• 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.

  PMID: 26714807 DERIVED

Study Officials

• Antonio Pesenti, MD

  San Gerardo Hospital

  PRINCIPAL INVESTIGATOR

• Giacomo Bellani, MD PhD

  San Gerardo Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: July 30, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

IT (1)