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Completed

NCT Number: NCT02120001

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

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.

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Key information

Conditions

Ventilator Associated Pneumonia Critical Illness Critically Ill Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

Several studies have suggested that biofilm formation inside the ETT plays a pivotal role in VAP development and drug-resistance induction. Silver-coated ETT have proven effective in delaying but not in preventing ETT colonization and biofilm formation, due to a barrier effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove debris and biofilm and reduce the total ETT microbial load to a certain extent. The Investigators hypothesize that the routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want to assess the reduction of ETT microbial colonization in patients intubated with a silver-coated ETT and cleaned with endOclear compared to the current standard of care of silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the tubes of each enrolled patient after it has been removed, either because the patient does not need it anymore due to his/her better clinical conditions, or because there is a need of tracheostomy or because he/she dies. Specifically they will analyze how the endOclear cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this can determine distal airway inoculation and, ultimately, VAP development.

Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization.

Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from microbial colonization will prevent septic inoculation of distal airways

Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm development will reduce drug resistance rates found in ETT and distal airways isolates

The investigators will conduct a randomized clinical trial on 40 patients intubated with silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the endOclear device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: endOclear

Primary outcomes

  1. Endotracheal Tube Colonization

    Time frame: At extubation (an expected average of 7 days)

    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).

Secondary outcomes

  1. Microbiological Colonization of Distal Airways

    Time frame: At extubation (An expected average of 7 days)

    Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Rhode Island Hospital

Registry information

Official study title

Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2014
Registry last updated
May 19, 2017

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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