Trial Outcomes & Findings for Efficacy Study on Silver-coated ETT Cleaned With a Novel Device (NCT NCT02120001)
NCT ID: NCT02120001
Last Updated: 2017-05-19
Results Overview
Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).
COMPLETED
NA
40 participants
At extubation (an expected average of 7 days)
2017-05-19
Participant Flow
Four patients were found ineligible.
Participant milestones
| Measure |
ETT Cleaning Maneuver
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
|
17
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study on Silver-coated ETT Cleaned With a Novel Device
Baseline characteristics by cohort
| Measure |
ETT Cleaning Maneuver
n=17 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=19 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=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At extubation (an expected average of 7 days)Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).
Outcome measures
| Measure |
ETT Cleaning Maneuver
n=17 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=19 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.
|
|---|---|---|
|
Endotracheal Tube Colonization
|
0.9 Log colony form unit (CFU)/ mL
Standard Deviation 1.2
|
1.6 Log colony form unit (CFU)/ mL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: At extubation (An expected average of 7 days)Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.
Outcome measures
| Measure |
ETT Cleaning Maneuver
n=17 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=19 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.
|
|---|---|---|
|
Microbiological Colonization of Distal Airways
|
4.2 Log colony form unit (CFU)/ mL
Standard Deviation 3.8
|
4.8 Log colony form unit (CFU)/ mL
Standard Deviation 4.0
|
Adverse Events
ETT Cleaning Maneuver
Standard of Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Kacmarek, Director Respiratory Care
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place