Trial Outcomes & Findings for Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE (NCT NCT02284178)
NCT ID: NCT02284178
Last Updated: 2019-08-15
Results Overview
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
513 participants
Primary outcome timeframe
Every 12 hours up to 14 days
Results posted on
2019-08-15
Participant Flow
Participant milestones
| Measure |
Enhanced Oral Suction
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
258
|
|
Overall Study
COMPLETED
|
206
|
204
|
|
Overall Study
NOT COMPLETED
|
49
|
54
|
Reasons for withdrawal
| Measure |
Enhanced Oral Suction
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Overall Study
Met exclusion criteria
|
49
|
54
|
Baseline Characteristics
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Baseline characteristics by cohort
| Measure |
Enhanced Oral Suction
n=255 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=258 Participants
Oropharyngeal suction with suction swab; standard oral cleansing every 4 hours.
|
Total
n=513 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.05 years
STANDARD_DEVIATION 18.93 • n=99 Participants
|
57.50 years
STANDARD_DEVIATION 18.69 • n=107 Participants
|
58.77 years
STANDARD_DEVIATION 18.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
217 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
296 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
203 Participants
n=99 Participants
|
215 Participants
n=107 Participants
|
418 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
50 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
196 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
382 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
255 Participants
n=99 Participants
|
258 Participants
n=107 Participants
|
513 Participants
n=206 Participants
|
|
APACHE 2
|
22.98 units on a scale
STANDARD_DEVIATION 7.21 • n=99 Participants
|
22.72 units on a scale
STANDARD_DEVIATION 7.94 • n=107 Participants
|
22.85 units on a scale
STANDARD_DEVIATION 7.58 • n=206 Participants
|
PRIMARY outcome
Timeframe: Every 12 hours up to 14 daysSpecimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.
Outcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Microaspiration as Measured by Tracheal Amylase
|
13,086 U/L
Standard Deviation 25,288
|
15,298 U/L
Standard Deviation 36,643
|
PRIMARY outcome
Timeframe: Every 12 hours up to 14 daysSpecimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria
Outcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
|
75.2 percentage specimens positive amylase
|
78.4 percentage specimens positive amylase
|
SECONDARY outcome
Timeframe: VAC assessed for 2 days beyond last intervention; mean 5.4 daysVAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.
Outcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Ventilator-Associated Condition (VAC) Rate
|
31 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: VAC was assessed for two days beyond the last intervention; mean 5.4 daysOutcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Time to VAC
|
4.94 Days
Standard Deviation 2.29
|
5.72 Days
Standard Deviation 2.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 12 hours up to 14 daysThe ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).
Outcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Tracheal to Oral Ratio of Amylase
|
0.073 Ratio of tracheal amylase to oral value
Standard Deviation 0.1
|
0.075 Ratio of tracheal amylase to oral value
Standard Deviation 0.2
|
POST_HOC outcome
Timeframe: Duration of Mechanical VentilationOutcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Clinical Outcome: Ventilator Hours
|
147.6 Hours
Standard Deviation 86.4
|
159.3 Hours
Standard Deviation 102.6
|
POST_HOC outcome
Timeframe: Duration of Intensive Care Unit StayOutcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Clinical Outcome: Intensive Care Unit Length of Stay
|
9.8 Days
Standard Deviation 6.6
|
10.8 Days
Standard Deviation 7.7
|
POST_HOC outcome
Timeframe: Duration of Hospital StayOutcome measures
| Measure |
Enhanced Oral Suction
n=206 Participants
Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours.
|
Usual Care Oral Suction
n=204 Participants
Oral suction with suction swab every 4 hours; standard oral cleansing every 4 hours.
|
|---|---|---|
|
Clinical Outcome: Hospital Length of Stay
|
19.5 Days
Standard Deviation 16.5
|
23.4 Days
Standard Deviation 23.1
|
Adverse Events
Enhanced Oral Suction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 41 deaths
Usual Care Oral Suction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 49 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place