Trial Outcomes & Findings for Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia (NCT NCT01744483)
NCT ID: NCT01744483
Last Updated: 2017-10-26
Results Overview
The percentage of patients with quantitative culture growth from tracheal aspirate specimens of \>1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Tracheal colonization by Day 4 or extubation
Results posted on
2017-10-26
Participant Flow
Patients undergoing emergency tracheal intubation. EMS routed Harborview Medical Center (HMC) or patients who required emergent tracheal intubation while in HMC.
Participant milestones
| Measure |
PVC ETT
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
35
|
38
|
|
Overall Study
COMPLETED
|
15
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
29
|
22
|
28
|
Reasons for withdrawal
| Measure |
PVC ETT
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
|---|---|---|---|
|
Overall Study
Death
|
9
|
4
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
11
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
2
|
|
Overall Study
No ICU Admit
|
5
|
1
|
2
|
|
Overall Study
Routed to OSH
|
2
|
0
|
1
|
Baseline Characteristics
Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia
Baseline characteristics by cohort
| Measure |
PVC ETT
n=36 Participants
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
n=32 Participants
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
n=34 Participants
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
32 participants
n=7 Participants
|
34 participants
n=5 Participants
|
102 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Tracheal colonization by Day 4 or extubationThe percentage of patients with quantitative culture growth from tracheal aspirate specimens of \>1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.
Outcome measures
| Measure |
PVC ETT
n=33 Participants
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
n=29 Participants
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
n=34 Participants
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
|---|---|---|---|
|
Percentage of Patients With Tracheal Bacterial Colonization
|
8 percentage of tracheal colonization
|
7 percentage of tracheal colonization
|
9 percentage of tracheal colonization
|
Adverse Events
PVC ETT
Serious events: 9 serious events
Other events: 1 other events
Deaths: 0 deaths
PUC ETT
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
PUC-CASS ETT
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PVC ETT
n=36 participants at risk
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
n=32 participants at risk
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
n=34 participants at risk
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
|---|---|---|---|
|
Cardiac disorders
Death from any cause
|
25.0%
9/36 • Number of events 9 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
15.6%
5/32 • Number of events 5 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
26.5%
9/34 • Number of events 9 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
Other adverse events
| Measure |
PVC ETT
n=36 participants at risk
Polyvinylchloride cuff endotracheal tube
PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation.
|
PUC ETT
n=32 participants at risk
Polyurethane cuff endotracheal tube
PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation.
|
PUC-CASS ETT
n=34 participants at risk
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Up to 2 months after extubation airway complications
|
2.8%
1/36 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
3.1%
1/32 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
0.00%
0/34 • Up to 2 months after extubation
Death or prolonged hospitalization related to ETT model
|
Additional Information
Dr Miriam Treggiari
Oregon Health Science & Science University
Phone: (503) 494-8311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place