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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120001
• Other study ID #: DAN1000AM
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: September 22, 2015
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Device:
• ETT cleaning maneuver
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. The cleaning device has a mechanically expandable mesh structure which can be adapted to selectively move between a radially-collapsed position and a radially-expanded one. 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotracheal tube colonization	Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation	At extubation (an expected average of 7 days)	No
Secondary	Microbiological colonization of distal airways	Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a sample of tracheal aspirate immediately before extubation.	At extubation (An expected average of 7 days)	No
Secondary	ETT microscopic imaging	Samples of ETT will be collected and stored for Scanned Electron Microscopy and Confocal Laser Scanning Microscopy with dead/alive staining	At extubation (An expected average of 7 days)	No
Secondary	In-vivo respiratory mechanics	Data about respiratory mechanics will be obtained in both groups for each enrolled patient three times a day (q8 hours). These measurements are safe non-invasive. They will require the RT to register pressure, volume and flow parameters from the ventilator in use on the patient.	At extubation (An expected average of 7 days)	No
Secondary	Drug resistance testing	Investigators will test drug resistances found in isolates of distal airways, tracheal aspirate and inner ETT surface	At extubation (An expected average of 7 days)	No
Secondary	Infective Processes and Clinical Outcomes	Investigators will keep track of patient data regarding ETT-related infections as well as data about ICU clinical outcomes (hours of mechanical ventilation, days of ICU stay, mortality, occurrence of tracheostomy and occurrence of ETT exchange)	At extubation (An expected average of 7 days)	No