# Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - Prevent 2 Study

> **NIH NIH R33** · DUKE UNIVERSITY · 2022 · $743,776

## Abstract

Project Summary
 Ventilator associated pneumonia (VAP) that occurs in critically ill patients who receive mechanical
ventilation is a serious nosocomial complication that can prolong hospitalization, increase mortality, and reduce
long term quality of life and cognitive function. Modification of the design of the endotracheal tube (ETT) that
allows continuous aspiration of subglottic secretions through an extra port positioned between the cuff and the
vocal cords may prevent leakage of contaminated secretions around the cuff and thereby reduce the risk of
VAP. The replacement of the standard polyvinylchloride (PVC) cuff material with polyurethane (PU) may
further protect from microaspiration. We previously successfully completed a randomized pilot controlled trial of
two modified ETTs in patients requiring emergency intubation to establish the feasibility of a larger trial to
address the long-term safety and effectiveness of modified ETTs.
 We propose a Phase II, randomized, controlled trial that will equally randomize patients requiring
emergency endotracheal intubation to receive either a PU-cuffed ETT equipped with continuous aspiration of
subglottic secretions (PU-CASS-ETT, n=537) or a conventional, PVC-cuffed ETT (PVC-ETT, n=537). Similar to
the pilot study, this trial will be conducted under Exception from Informed Consent (EFIC) in the four adult ICUs
at Oregon Health & Science University. The units of randomization will be the intubation kits which will contain
in a concealed manner one of the two ETT models provided in duplicate in two appropriate gender-specific
sizes. The trial primary aim is to determine if PU-CASS-ETT is as safe as PVC-ETT and if long-term patient
quality of life and cognitive function are better in PU-CASS-ETT, compared with PVC-ETT. The co-primary
safety endpoint is the evaluation of the safety profile based on upper airway-related complications and
laryngeal dysfunction collected via in person interview, compared with the PVC-ETT, at 6 months after
randomization. We will also monitor any device-related adverse events. Our co-primary effectiveness endpoint
is quality of life, as measured by the Medical Outcomes Study 36-item Short-Form General Health Survey, and
cognitive function, as assessed by the National Alzheimer Coordinating Center's Uniform Data Set, at 6
months after randomization. The secondary endpoints include the incidence of infection-related ventilator
associated conditions (IVAC) and ventilator associated events (VAEs), as defined by the Center for Disease
Control, respiratory antibiotics use, incidence of “clinical” VAP, 28-day ventilator-free days, mean daily
Sequential Organ Failure Assessment (SOFA) score, length of ICU and hospital stay, and mortality up to six
months will serve to evaluate other clinical meaningful consequences resulting from the occurrence of VAP.
Furthermore, the study will perform economic evaluation (cost-consequence approach) of quality of life,
healthcare resource utiliz...

## Key facts

- **NIH application ID:** 10657255
- **Project number:** 7R33HL138650-05
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Miriam Treggiari
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $743,776
- **Award type:** 7
- **Project period:** 2022-09-19 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10657255

## Citation

> US National Institutes of Health, RePORTER application 10657255, Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - Prevent 2 Study (7R33HL138650-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10657255. Licensed CC0.

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