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

Phase 2

Completed

• Conditions: Intubation; Expected Duration of Ventilation > 48h
• Interventions: Device: standard closed suctioning systems; Device: Airway medix closed suction system

• Registration Number: NCT01912105
• Lead Sponsor: Azienda Ospedaliera San Gerardo di Monza

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	standard closed suctioning systems	standard closed suctioning systems
treatment	Airway medix closed suction system	Airway Medix Closed Suction System

Primary Outcome Measures

Name	Time	Method
Volume of secretions	within 12 hours after extubation	Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan

Secondary Outcome Measures

Name	Time	Method
adverse events	until extubation, death or tracheostomy (approximately 2 weeks)	report of major and minor adverse events related to the use of the device

Trial Locations

Locations (1)

Azienda Ospedaliera San Gerardo; 🇮🇹 Monza, Italy