Efficacy Study on Silver-coated ETT Cleaned With a Novel Device

NCT02120001 | Completed Results

• 1 other identifier: DAN1000AM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.

Conditions

Ventilator Associated Pneumonia; Critically Ill

Keywords

Medical Devices; Ventilator-Associated Pneumonia (VAP); Ventilator-Associated Events (VAE); Endotracheal Tube; Microbial Diversity; Drug-Resistance; biofilms; endotracheal intubation; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Endotracheal Tube Colonization

  Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).

  At extubation (an expected average of 7 days)

Secondary Outcomes (1)

• Microbiological Colonization of Distal Airways

  At extubation (An expected average of 7 days)

Study Arms (2)

ETT cleaning maneuver

EXPERIMENTAL

Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.

Device: ETT cleaning maneuver

Standard of care

NO INTERVENTION

In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.

Interventions

ETT cleaning maneuver DEVICE

EndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions. We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.

Also known as: endOclear

ETT cleaning maneuver

Eligibility Criteria

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

You may qualify if:

• Admission to Medical, Surgical or Neuro ICU
• Subjects must be enrolled within 24 hours from intubation
• Subjects expected to be intubated for at least 48 hours or longer
• Subjects have been intubated with a silver-coated ETT

You may not qualify if:

• Current and past participation in another interventional trial conflicting with the present study
• Pregnant women
• Prisoner status

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Pirrone M, Imber DA, Marrazzo F, Pinciroli R, Zhang C, Bry L, Delaney ML, Dubois AM, Thomas JG, Nistico L, Melton-Kreft R, Bittner EA, Kacmarek RM, Berra L. Silver-Coated Endotracheal Tubes Cleaned With a Mechanism for Secretion Removal. Respir Care. 2019 Jan;64(1):1-9. doi: 10.4187/respcare.06222. Epub 2018 Sep 4.

  PMID: 30181363 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Critical Illness

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Kacmarek, Director Respiratory Care
• Organization: Massachusetts General Hospital

rkacmarek@mgh.harvard.edu

(617) 726-2000

Study Officials

• Robert Kacmarek, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia and Critical Care MD

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Locations

US (1)