Airway Control, Airway Obstruction, Breathing Mechanics, Endotracheal Extubation, Pneumonia, Ventilator-Associated
Conditions
Keywords
Medical Devices, Ventilator-Associated Pneumonia (VAP), Ventilator-Associated Events (VAE), Endotracheal Tube, Microbial Diversity, Anti-Resistance, Computed Tomography (CT)
Brief summary
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.
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.
Interventions
DEVICEETT cleaning maneuver
EndOclear device will be used for ETT cleaning maneuver. This is a commercially available device. It consists of an ETT 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 ETT. The cleaning apparatus is then pulled out of the ETT removing mucus deposits and secretions. We will add endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.
Sponsors
West Virginia University
endOclear, LLC.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs | At extubation (An expected average of 5 days) | The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ETT Microbiology | At extubation (An expected average of 5 days) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | ETT Cleaning Manuver | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 19 | 64 years STANDARD_DEVIATION 17 | 62 years STANDARD_DEVIATION 18 |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs
The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.
Time frame: At extubation (An expected average of 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETT Cleaning Manuver | Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs | 10.6 percentage of occlusion | Standard Deviation 8 |
| Standard of Care | Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs | 17.7 percentage of occlusion | Standard Deviation 13.4 |
Secondary
ETT Microbiology
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.
Time frame: At extubation (An expected average of 5 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETT Cleaning Manuver | ETT Microbiology | 2.89 Log colony form unit (CFU)/ mL | Standard Error 0.49 |
| Standard of Care | ETT Microbiology | 3.35 Log colony form unit (CFU)/ mL | Standard Error 0.48 |