Efficacy Study of a Novel Device to Clean the Endotracheal Tube

Mass General Brigham

Status: Completed

Conditions: Airway Control; Pneumonia, Ventilator-Associated; Endotracheal Extubation; Breathing Mechanics; Airway Obstruction

Treatments: Device: ETT cleaning maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT01765530

MGH-ETT cleaning

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

ETT cleaning manuver

Experimental group

Description:

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.

Treatment:

Device: ETT cleaning maneuver

Standard of care

No Intervention group

Description:

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