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 (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.

• 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=5 Participants	57.50 years STANDARD_DEVIATION 18.69 • n=7 Participants	58.77 years STANDARD_DEVIATION 18.83 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	112 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	146 Participants n=7 Participants	296 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	52 Participants n=5 Participants	43 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	203 Participants n=5 Participants	215 Participants n=7 Participants	418 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	54 Participants n=7 Participants	104 Participants n=5 Participants
Race (NIH/OMB) White	196 Participants n=5 Participants	186 Participants n=7 Participants	382 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	255 Participants n=5 Participants	258 Participants n=7 Participants	513 Participants n=5 Participants
APACHE 2	22.98 units on a scale STANDARD_DEVIATION 7.21 • n=5 Participants	22.72 units on a scale STANDARD_DEVIATION 7.94 • n=7 Participants	22.85 units on a scale STANDARD_DEVIATION 7.58 • n=5 Participants

PRIMARY outcome

Timeframe: Every 12 hours up to 14 days

Specimens 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 days

Specimens 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 days

VAC 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 days

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.
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 days

The 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 Ventilation

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.
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 Stay

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.
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 Stay

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.
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

Mary Lou Sole

University of Central Florida

Phone: 407-823-5496

Email: mary.sole@ucf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place