Ventilator-acquired PneumoniaPhase 2PreVent2NCT03705286
Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia
A Phase 2 study testing EVAC-PU-ETT and PVC-ETT in people with Ventilator-acquired Pneumonia, run by Yale University at 1 site in United States.
Trial summary
Researchers are looking at two different types of breathing tubes to see if one is better than the other at preventing pneumonia. One of the tubes has a design features to prevent leakage of fluids from the mouth and the back of the throat into the lower airways and lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-acquired Pneumonia
- What is being tested?
- EVAC-PU-ETT and PVC-ETT
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,074 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2019to 23 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Requiring emergency endotracheal intubation in the ED or in-hospital for acute respiratory distress or failure
- A study intubation kit containing the study ID number must have been used for the emergency intubation
- Admitted to the ICU and receiving mechanical ventilation
Who cannot join
- Patients electively intubated in the operating room whether or not they require subsequent ICU admission
- Use of a non-study designated intubation kit (such as nasal intubation, tracheotomy, intubation occurring at a location not supplied with the study intubation kits)
- Patients with permanent tracheostomy
- Protected populations including children (age <18 years), pregnant women, or prisoners
- Evidence of unwillingness to participate in a research study as documented in the patient's electronic health record, or at the time of intubation if there is opportunity to read the opt-out script.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06511
About this study
Official title: Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study
Researchers are looking at two different types of breathing tubes to see if one is better than the other at preventing pneumonia. One of the tubes has a design features to prevent leakage of fluids from the mouth and the back of the throat into the lower airways and lungs. This is important since leakage of small amounts of fluid into the lungs may lead to pneumonia. The other tube is the standard tube used at most hospitals.
The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs will reduce the risk of developing pneumonia and improve quality of life and cognitive function, compared to the standard tube. The study will also look at the safety of the modified breathing tube, compared to the standard tube.
Read the detailed description
The proposed study will be a randomized, controlled trial, conducted under Exception From Informed Consent (EFIC), comparing patients who undergo emergency tracheal intubation with one of two different endotracheal tubes (ETTs), one of which is designed to prevent ventilator-associated pneumonia (VAP): 1) An ETT fitted with a lumen to allow continuous aspiration of subglottic secretions and made with a polyurethane cuff (EVAC-PU-ETT); and 2) A standard ETT with a polyvinylchloride cuff (PVC-ETT). Approximately 1,074 adult patients requiring endotracheal intubation in the ED or hospital for acute respiratory distress or failure will be randomly assigned in an equal fashion to be intubated with one of the two ETTs (537 patients in each group). Because endotracheal intubation is performed in an emergency setting, the unit of randomization will be the intubation kits containing, in a concealed manner, one of the two types of ETT. The intubation kits are placed in areas where emergency intubation teams receive their intubation equipment supplies, primarily in the ICUs and in the emergency department. The study is designed to allow all patients requiring emergency intubation to be potentially eligible for enrollment to ensure the applicability of the study findings to a generalizable setting of patients receiving emergency intubation outside the operating room.
The trial primary aim is to determine if EVAC-PU-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 investigators will also monitor any device-related adverse events. Additional 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 utilization and cost for hospitals. Primary and secondary endpoints will be compared between the PU-CASS-ETT and PVC-ETT groups, using an intention-to-treat approach.
- Conditions
- Ventilator-acquired Pneumonia
- Being tested
- EVAC-PU-ETT, PVC-ETT
- Keywords
- Pneumonia, Endotracheal intubation
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVAC-PU-ETTDevice
Also called Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy Eye
Placement of a EVAC-PU-ETT in the setting of emergent intubation.
PVC-ETTDevice
Also called Shiley™ Cuffed Basic Endotracheal Tube
Placement of a PVC-ETT in the setting of emergent intubation.
| Study group | Role | What they receive |
|---|---|---|
| PVC-ETT | Active comparator | Polyvinylchloride endotracheal tube Receives: Device: PVC-ETT |
| EVAC-PU-ETT | Experimental | Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube Receives: Device: EVAC-PU-ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - 36-item Short-Form General Health Survey
Physical Component Score and Mental Component Score each have scores that range from 0 - 100; Lower scores = more disability, higher scores = less disability.
Measured: 6 months
Cognitive Function
Percentage of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set
Measured: 6 months
Secondary outcomes (1)
Airway Related Complications
The number of participants that experienced airway related adverse events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start6 May 2019
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,074 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University
- Responsible party
- Principal investigator, Miriam Treggiari, Yale University
- Investigators
- Miriam M Treggiari, MD, PhD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705286
- Sponsor's protocol ID
- 2000027877
- Other IDs
- R33HL138650
- Acronym
- PreVent2
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2018
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Treggiari MM, Sharp ES, Ohnuma T, Fajardo EC, Aydin A, Akhtar S, Kampp M, Hashemaghaie M, Potnis A, Gugel T, Simon J, Curry LG, Adams K, Darji B, Sureshanand S, Hintz R, Lorzano SN, Johnson C, Yanez ND. Hospital and long-term outcomes for subglottic suction and polyurethane cuff versus standard endotracheal tubes in emergency intubation (PreVent 2): a randomised controlled phase 2 trial. Lancet Respir Med. 2026 Feb;14(2):141-150. doi: 10.1016/S2213-2600(25)00294-2. Epub 2025 Nov 27.
PubMed 41319662Gugel T, Adams K, Baranoski M, Yanez ND, Kampp M, Johnson T, Aydin A, Fajardo EC, Sharp E, Potnis A, Johnson C, Treggiari MM. Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic. Clin Trials. 2024 Dec;21(6):671-680. doi: 10.1177/17407745241243045. Epub 2024 Apr 27.
PubMed 38676438
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study
- ClinicalTrials.gov ID
- NCT03705286
- Acronym / sponsor ID
- PreVent2 / 2000027877
- Conditions
- Ventilator-acquired Pneumonia
- Keywords
- Pneumonia, Endotracheal intubation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,074 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University
- Study start
- 6 May 2019 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 24 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking at two different types of breathing tubes to see if one is better than the other at preventing pneumonia. One of the tubes has a design features to prevent leakage of fluids from the mouth and the back of the throat into the lower airways and lungs. This is important since leakage of small amounts of fluid into the lungs may lead to pneumonia. The other tube is the standard tube used at most hospitals.
The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs will reduce the risk of developing pneumonia and improve quality of life and cognitive function, compared to the standard tube. The study will also look at the safety of the modified breathing tube, compared to the standard tube.
Detailed description
The proposed study will be a randomized, controlled trial, conducted under Exception From Informed Consent (EFIC), comparing patients who undergo emergency tracheal intubation with one of two different endotracheal tubes (ETTs), one of which is designed to prevent ventilator-associated pneumonia (VAP): 1) An ETT fitted with a lumen to allow continuous aspiration of subglottic secretions and made with a polyurethane cuff (EVAC-PU-ETT); and 2) A standard ETT with a polyvinylchloride cuff (PVC-ETT). Approximately 1,074 adult patients requiring endotracheal intubation in the ED or hospital for acute respiratory distress or failure will be randomly assigned in an equal fashion to be intubated with one of the two ETTs (537 patients in each group). Because endotracheal intubation is performed in an emergency setting, the unit of randomization will be the intubation kits containing, in a concealed manner, one of the two types of ETT. The intubation kits are placed in areas where emergency intubation teams receive their intubation equipment supplies, primarily in the ICUs and in the emergency department. The study is designed to allow all patients requiring emergency intubation to be potentially eligible for enrollment to ensure the applicability of the study findings to a generalizable setting of patients receiving emergency intubation outside the operating room.
The trial primary aim is to determine if EVAC-PU-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 investigators will also monitor any device-related adverse events. Additional 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 utilization and cost for hospitals. Primary and secondary endpoints will be compared between the PU-CASS-ETT and PVC-ETT groups, using an intention-to-treat approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVC-ETT | Active comparator | Device: PVC-ETTPolyvinylchloride endotracheal tube |
| EVAC-PU-ETT | Experimental | Device: EVAC-PU-ETTContinuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Requiring emergency endotracheal intubation in the ED or in-hospital for acute respiratory distress or failure
- A study intubation kit containing the study ID number must have been used for the emergency intubation
- Admitted to the ICU and receiving mechanical ventilation
Key exclusion criteria (5 listed)
- Patients electively intubated in the operating room whether or not they require subsequent ICU admission
- Use of a non-study designated intubation kit (such as nasal intubation, tracheotomy, intubation occurring at a location not supplied with the study intubation kits)
- Patients with permanent tracheostomy
- Protected populations including children (age <18 years), pregnant women, or prisoners
- Evidence of unwillingness to participate in a research study as documented in the patient's electronic health record, or at the time of intubation if there is opportunity to read the opt-out script.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVAC-PU-ETTAlso: Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy EyePlacement of a EVAC-PU-ETT in the setting of emergent intubation. | Device | EVAC-PU-ETT |
| PVC-ETTAlso: Shiley™ Cuffed Basic Endotracheal TubePlacement of a PVC-ETT in the setting of emergent intubation. | Device | PVC-ETT |
Primary outcome
Quality of Life - 36-item Short-Form General Health Survey
Time frame: 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.
Cognitive Function
Time frame: 6 months
Percentage of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set
1 secondary outcome
Airway Related Complications
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41319662Treggiari MM, Sharp ES, Ohnuma T, Fajardo EC, Aydin A, Akhtar S, Kampp M, Hashemaghaie M, Potnis A, Gugel T, Simon J, Curry LG, Adams K, Darji B, Sureshanand S, Hintz R, Lorzano SN, Johnson C, Yanez ND. Hospital and long-term outcomes for subglottic suction and polyurethane cuff versus standard endotracheal tubes in emergency intubation (PreVent 2): a randomised controlled phase 2 trial. Lancet Respir Med. 2026 Feb;14(2):141-150. doi: 10.1016/S2213-2600(25)00294-2. Epub 2025 Nov 27.
- Derived from this study: PubMed 38676438Gugel T, Adams K, Baranoski M, Yanez ND, Kampp M, Johnson T, Aydin A, Fajardo EC, Sharp E, Potnis A, Johnson C, Treggiari MM. Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic. Clin Trials. 2024 Dec;21(6):671-680. doi: 10.1177/17407745241243045. Epub 2024 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam M Treggiari, MD, PhD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVAC-PU-ETT and PVC-ETT in people with Ventilator-acquired Pneumonia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - 36-item Short-Form General Health Survey (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.