Respiratory Failure
Conditions
Keywords
mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events
Brief summary
Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.
Interventions
OTHEREnhanced oropharyngeal suction
Deep oropharyngeal suction with catheter every 4 hours
OTHERUsual Care
Oral suction with suction swab every 4 hours
Sponsors
Orlando Regional Medical Center
University of Central Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * orally intubated with endotracheal tube and treated with mechanical ventilation * 24 hours or less since intubation * expected to be intubated for at least 36 hours after enrollment
Exclusion criteria
* documented aspiration at time of intubation * intubation to treat known aspiration * treatment with rescue mechanical ventilation therapies (oscillator) * re-intubation * contraindications to receiving the intervention (e.g., oral injuries) * history of lung or head/neck cancers that may produce amylase in the lungs * history of disease that affects saliva production (e.g., Sjögren's syndrome) * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microaspiration as Measured by Tracheal Amylase | 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. |
| Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Associated Condition (VAC) Rate | 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. |
| Time to VAC | VAC was assessed for two days beyond the last intervention; mean 5.4 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tracheal to Oral Ratio of Amylase | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Oral Suction Deep oropharyngeal suction with catheter every 4 hours; standard oral cleansing every 4 hours. | 255 |
| Usual Care Oral Suction Oropharyngeal suction with suction swab; standard oral cleansing every 4 hours. | 258 |
| Total | 513 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Met exclusion criteria | 49 | 54 |
Baseline characteristics
| Characteristic | Enhanced Oral Suction | Usual Care Oral Suction | Total |
|---|---|---|---|
| Age, Continuous | 60.05 years STANDARD_DEVIATION 18.93 | 57.50 years STANDARD_DEVIATION 18.69 | 58.77 years STANDARD_DEVIATION 18.83 |
| APACHE 2 | 22.98 units on a scale STANDARD_DEVIATION 7.21 | 22.72 units on a scale STANDARD_DEVIATION 7.94 | 22.85 units on a scale STANDARD_DEVIATION 7.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 43 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants | 215 Participants | 418 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 15 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 54 Participants | 104 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 196 Participants | 186 Participants | 382 Participants |
| Region of Enrollment United States | 255 Participants | 258 Participants | 513 Participants |
| Sex: Female, Male Female | 105 Participants | 112 Participants | 217 Participants |
| Sex: Female, Male Male | 150 Participants | 146 Participants | 296 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 41 / 206 | 49 / 204 |
| other Total, other adverse events | 0 / 206 | 0 / 204 |
| serious Total, serious adverse events | 0 / 206 | 0 / 204 |
Outcome results
Primary
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria
Time frame: Every 12 hours up to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Oral Suction | Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | 75.2 percentage specimens positive amylase |
| Usual Care Oral Suction | Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | 78.4 percentage specimens positive amylase |
p-value: 0.684GEE
Primary
Microaspiration as Measured by Tracheal Amylase
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.
Time frame: Every 12 hours up to 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Oral Suction | Microaspiration as Measured by Tracheal Amylase | 13,086 U/L |
| Usual Care Oral Suction | Microaspiration as Measured by Tracheal Amylase | 15,298 U/L |
p-value: 0.432GEE analysis
Secondary
Time to VAC
Time frame: VAC was assessed for two days beyond the last intervention; mean 5.4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Oral Suction | Time to VAC | 4.94 Days | Standard Deviation 2.29 |
| Usual Care Oral Suction | Time to VAC | 5.72 Days | Standard Deviation 2.53 |
Secondary
Ventilator-Associated Condition (VAC) Rate
VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.
Time frame: VAC assessed for 2 days beyond last intervention; mean 5.4 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Oral Suction | Ventilator-Associated Condition (VAC) Rate | 31 Participants |
| Usual Care Oral Suction | Ventilator-Associated Condition (VAC) Rate | 32 Participants |
p-value: 0.858Chi-squared
Post Hoc
Clinical Outcome: Hospital Length of Stay
Time frame: Duration of Hospital Stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Oral Suction | Clinical Outcome: Hospital Length of Stay | 19.5 Days | Standard Deviation 16.5 |
| Usual Care Oral Suction | Clinical Outcome: Hospital Length of Stay | 23.4 Days | Standard Deviation 23.1 |
p-value: 0.05t-test, 2 sided
Post Hoc
Clinical Outcome: Intensive Care Unit Length of Stay
Time frame: Duration of Intensive Care Unit Stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Oral Suction | Clinical Outcome: Intensive Care Unit Length of Stay | 9.8 Days | Standard Deviation 6.6 |
| Usual Care Oral Suction | Clinical Outcome: Intensive Care Unit Length of Stay | 10.8 Days | Standard Deviation 7.7 |
p-value: 0.155t-test, 2 sided
Post Hoc
Clinical Outcome: Ventilator Hours
Time frame: Duration of Mechanical Ventilation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Oral Suction | Clinical Outcome: Ventilator Hours | 147.6 Hours | Standard Deviation 86.4 |
| Usual Care Oral Suction | Clinical Outcome: Ventilator Hours | 159.3 Hours | Standard Deviation 102.6 |
p-value: 0.214t-test, 2 sided
Other Pre-specified
Tracheal to Oral Ratio of Amylase
The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).
Time frame: Every 12 hours up to 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Oral Suction | Tracheal to Oral Ratio of Amylase | 0.073 Ratio of tracheal amylase to oral value | Standard Deviation 0.1 |
| Usual Care Oral Suction | Tracheal to Oral Ratio of Amylase | 0.075 Ratio of tracheal amylase to oral value | Standard Deviation 0.2 |
p-value: 0.46GEE analysis