Trial Outcomes & Findings for Efficacy Study of a Novel Device to Clean the Endotracheal Tube (NCT NCT01765530)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

At extubation (An expected average of 5 days)

Results posted on

2017-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	37	37
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy Study of a Novel Device to Clean the Endotracheal Tube

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ETT Cleaning Manuver n=36 Participants 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.	Standard of Care n=36 Participants In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.	Total n=72 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 19 • n=5 Participants	64 years STANDARD_DEVIATION 17 • n=7 Participants	62 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETT Cleaning Manuver n=36 Participants 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.	Standard of Care n=36 Participants In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs	10.6 percentage of occlusion Standard Deviation 8.0	17.7 percentage of occlusion Standard Deviation 13.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ETT Cleaning Manuver n=36 Participants 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.	Standard of Care n=36 Participants In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
ETT Microbiology	2.89 Log colony form unit (CFU)/ mL Standard Error 0.49	3.35 Log colony form unit (CFU)/ mL Standard Error 0.48

Adverse Events

ETT Cleaning Manuver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert M Kacmarek PhD, RRT

Massachusetts General Hospital

Phone: 617-724-4490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place