Trial Outcomes & Findings for Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia (NCT NCT03705286)

NCT ID: NCT03705286

Last Updated: 2024-09-24

Results Overview

Physical Component Score and Mental Component Score each have scores that range from 0 - 100; Lower scores = more disability, higher scores = less disability.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1074 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-09-24

Participant Flow

4 patients inadvertently enrolled; 2 patients refused continued participation

Participant milestones

Measure	PVC-ETT Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.
Overall Study STARTED	533	535
Overall Study COMPLETED	87	70
Overall Study NOT COMPLETED	446	465

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia

Baseline characteristics by cohort

Measure	PVC-ETT n=533 Participants Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT n=535 Participants Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.	Total n=1068 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 15.4 • n=5 Participants	63.1 years STANDARD_DEVIATION 16.1 • n=7 Participants	62.9 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	201 Participants n=5 Participants	196 Participants n=7 Participants	397 Participants n=5 Participants
Sex: Female, Male Male	332 Participants n=5 Participants	339 Participants n=7 Participants	671 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	102 Participants n=5 Participants	100 Participants n=7 Participants	202 Participants n=5 Participants
Race (NIH/OMB) White	359 Participants n=5 Participants	359 Participants n=7 Participants	718 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	55 Participants n=5 Participants	63 Participants n=7 Participants	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Physical Component Score and Mental Component Score each have scores that range from 0 - 100; Lower scores = more disability, higher scores = less disability.

Outcome measures

Measure	PVC-ETT n=69 Participants Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT n=84 Participants Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.
Quality of Life - 36-item Short-Form General Health Survey Physical Component Score	40.5 score on a scale Standard Deviation 11.9	40.0 score on a scale Standard Deviation 13.1
Quality of Life - 36-item Short-Form General Health Survey Mental Component Score	48.9 score on a scale Standard Deviation 12.2	45.9 score on a scale Standard Deviation 13.1

PRIMARY outcome

Timeframe: 6 months

Percentage of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set

Outcome measures

Measure	PVC-ETT n=67 Participants Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT n=82 Participants Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.
Cognitive Function	54 Participants	70 Participants

SECONDARY outcome

Timeframe: 6 months

The number of participants that experienced airway related adverse events.

Outcome measures

Measure	PVC-ETT n=70 Participants Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT n=86 Participants Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.
Airway Related Complications	49 participants	71 participants

Adverse Events

PVC-ETT

Serious events: 0 serious events

Other events: 49 other events

Deaths: 284 deaths

EVAC-PU-ETT

Serious events: 0 serious events

Other events: 71 other events

Deaths: 274 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PVC-ETT n=533 participants at risk Polyvinylchloride endotracheal tube PVC-ETT: Placement of a PVC-ETT in the setting of emergent intubation.	EVAC-PU-ETT n=535 participants at risk Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube EVAC-PU-ETT: Placement of a EVAC-PU-ETT in the setting of emergent intubation.
Product Issues Cuff leak	0.38% 2/533 • Number of events 2 • up to 6 months These are all adverse events that were collected during the hospitalization period.	1.1% 6/535 • Number of events 6 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Injury, poisoning and procedural complications Orophrayngeal injury	0.00% 0/533 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.19% 1/535 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Respiratory, thoracic and mediastinal disorders Unplanned extubation	0.00% 0/533 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.19% 1/535 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Product Issues Cuff under-inflated	0.19% 1/533 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.19% 1/535 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Product Issues Cuff rupture	0.38% 2/533 • Number of events 2 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.00% 0/535 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Product Issues Pilot balloon damage	0.38% 2/533 • Number of events 2 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.56% 3/535 • Number of events 3 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Product Issues ETT connection mulfunction	0.19% 1/533 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.00% 0/535 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Respiratory, thoracic and mediastinal disorders Failed extubation	0.00% 0/533 • up to 6 months These are all adverse events that were collected during the hospitalization period.	0.19% 1/535 • Number of events 1 • up to 6 months These are all adverse events that were collected during the hospitalization period.
Respiratory, thoracic and mediastinal disorders Airway Related Complications	70.0% 49/70 • Number of events 49 • up to 6 months These are all adverse events that were collected during the hospitalization period.	82.6% 71/86 • Number of events 71 • up to 6 months These are all adverse events that were collected during the hospitalization period.

Additional Information

Miriam Treggiari

Duke University

Phone: 919-681-9933

Email: miriam.treggiari@duke.edu

Results disclosure agreements

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