Efficacy Study of a Novel Device to Clean the Endotracheal Tube

This study has been completed.
Sponsor:
Collaborators:
West Virginia University
endOclear, LLC.
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01765530
First received: December 28, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear) for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume measured at extubation compared to the current standard of care. The device may therefore be clinically useful by better maintaining the ETT original function.


Condition Intervention Phase
Endotracheal Extubation
Airway Obstruction
Airway Control
Pneumonia, Ventilator-Associated
Breathing Mechanics
Device: ETT cleaning maneuver
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Endotracheal Tubes Cleaned With a Novel Mechanism for Secretions Removal

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Endotracheal Tube endoluminal residual volume [ Time Frame: At extubation (An expected average of 5 days) ] [ Designated as safety issue: No ]
    Implementing an original technique by Thomas, et al. (Interscience Conference on Antimicrobial Agents and Chemotherapy. 2006, San Francisco,CA. ICAAC06-A-2966-ASM), the investigators will measure the size of the inner lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs with subsequent reconstruction and analysis by use of dedicated software. The whole ETT will be analyzed through hig-definition CT slices, with detection of the plastic-mucus-air interfaces resulting in multiple measurement of the ETT cross-sectional area (CSA). The investigators will calculate the luminal residual air volume, the total volume of mucus and all the associated measurements, such as lowest CSA. Comparing the volume of the used ETT to a blank clean same-size one, the investigators will also measure the relative loss of volume (%) due to mucus accumulation.


Secondary Outcome Measures:
  • ETT Microbiology [ Time Frame: At extubation (An expected average of 5 days) ] [ Designated as safety issue: No ]
    For each patient a quantitative culture will be obtained from the ETT after extubation. Secretions will be retrieved from the ETT after CT scan and quantitative standard cultures will be performed. Microbial molecular diversity analysis and antibacterial resistance patterns will also be studied.

  • ETT microscopic imaging [ Time Frame: At extubation (An expected average of 5 days) ] [ Designated as safety issue: No ]
    Samples of the ETT will be collected and stored in glutaraldehyde for subsequent Scanned Electron Microscopy (SEM) and Confocal Microscopy (CM) analysis.

  • In-vivo respiratory mechanics [ Time Frame: Three times a day (An expected average of 5 days) ] [ Designated as safety issue: No ]
    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.

  • User's feedback [ Time Frame: At extubation (An expected average of 5 days) ] [ Designated as safety issue: Yes ]
    To evaluate the feasibility and efficacy of the endOclear, the investigators will administer an anonymous questionnaire to the RTs who will use the device during the study. RTs will be asked to evaluate the device on three clinical issues: efficacy in cleaning the ETT of the endOclear, safety of the new maneuver, and feasibility for future intensive care unit implementation. Nurses assisting the procedure will be asked for their anonymous opinion too. Outside of this final survey, users will be instructed to timely report to the investigators any concern regarding safety of the device or adverse events.

  • ETT weight gain [ Time Frame: At extubation (An expected average of 5 days) ] [ Designated as safety issue: No ]
    Weight gain of the ETT due to secretions will be measured by mean of a high precision laboratory scale.


Enrollment: 74
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETT cleaning manuver
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

The ETT cleaning maneuver will be performed through the endOclear device. This 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.

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

Detailed Description:

After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is coated with a thick bacterial biofilm, which is a potential source for bacterial colonization of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of mucus/secretions on the interior of the ETT also effectively lowers the cross section of the ETT and increases significantly the work of breathing in intubated patients, who then require increased MV support, with prolonged intubation and ICU stay.

A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT microbial colonization and ultimately VAP incidence. To meet this goal several airways technologies to maintain the ETT free from debris/bacteria have been developed in order to improve the current ventilator-liberation standards in intubated critically ill patients.

Based on preliminary laboratory, animal and clinical data, The investigators now wish to test the hypothesis that a novel commercially available ETT cleaning device can be effective in targeting two specific issues:

  • Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.
  • Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower degree of microbial colonization for the entire period of mechanical ventilation.

Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic resistance analysis, users' feedbacks and safety of the device will also be collected.

The investigators will conduct a clinical trial on 74 intubated patients randomized to receive standard ETT cleaning or cleaning with the EndOclear.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients expected to be intubated for at least 48 hours or longer
  • Enrollment within 24 hours from intubation time

Exclusion Criteria:

  • Current and past participation in another intervention trial conflicting with the present study
  • Pregnant women and prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765530

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
West Virginia University
endOclear, LLC.
Investigators
Principal Investigator: Robert M Kacmarek, PhD, RRT Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Robert M. Kacmarek, Director, Respiratory Care Services; Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01765530     History of Changes
Other Study ID Numbers: MGH-ETT cleaning
Study First Received: December 28, 2012
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Medical Devices
Ventilator-Associated Pneumonia (VAP)
Ventilator-Associated Events (VAE)
Endotracheal Tube
Microbial Diversity
Anti-Resistance
Computed Tomography (CT)

Additional relevant MeSH terms:
Airway Obstruction
Respiratory Aspiration
Pneumonia
Pneumonia, Ventilator-Associated
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on April 16, 2014