Evidence map›Paper›PMID 41319662›Full record

Trial reportThe Lancet. Respiratory medicine2026

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.

Miriam M Treggiari, Emily S Sharp, Tetsu Ohnuma, Elaine C Fajardo, Ani Aydin, Shamsuddin Akhtar, Michael Kampp, Mona Hashemaghaie, Aartee Potnis, Tom Gugel and 9 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Respiratory medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03705286 (Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03705286 phase2completednot on this map

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

TypeinterventionalSponsorYale UniversityRan2019 to 2023Enrolled1,074ConditionsVentilator-acquired PneumoniaArmsEVAC-PU-ETT, PVC-ETT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Miriam M TreggiariDepartment of Anaesthesiology, Duke University School of Medicine, Duke University, Durham, NC, USA; Department of Neurology, Yale University, New Haven, CT, USA. Electronic address: miriam.treggiari@duke.edu.
Emily S SharpDepartment of Neurology, Yale University, New Haven, CT, USA.
Tetsu OhnumaDepartment of Anaesthesiology, Duke University School of Medicine, Duke University, Durham, NC, USA.
Elaine C FajardoDepartment of Medicine, Yale University, New Haven, CT, USA.
Ani AydinDepartment of Emergency Medicine, Yale University, New Haven, CT, USA.
Shamsuddin AkhtarDepartment of Anaesthesiology, Yale University, New Haven, CT, USA.
Michael KamppDepartment of Neurology, Yale University, New Haven, CT, USA.
Mona HashemaghaieDepartment of Anaesthesiology, Duke University School of Medicine, Duke University, Durham, NC, USA.
Aartee PotnisDepartment of Anaesthesiology, Yale University, New Haven, CT, USA.
Tom GugelDepartment of Anaesthesiology, Yale University, New Haven, CT, USA.
Jamarc SimonDepartment of Anaesthesiology, Duke University School of Medicine, Duke University, Durham, NC, USA.
Lazaro G CurryDepartment of Anaesthesiology, Yale University, New Haven, CT, USA.
Karen AdamsUniversity of Washington, Seattle, WA, USA.
Bhavin DarjiResearch Informatics Office, Yale University, New Haven, CT, USA.
Soundari SureshanandResearch Informatics Office, Yale University, New Haven, CT, USA.
Richard HintzResearch Informatics Office, Yale University, New Haven, CT, USA.
Samantha N LorzanoDepartment of Neurology, Yale University, New Haven, CT, USA.
Chanel JohnsonDepartment of Anaesthesiology, Yale University, New Haven, CT, USA.
N David YanezDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke University, Durham, NC, USA.

Funding

Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - Prevent 2 StudyR33HL138650 · NHLBI · YALE UNIVERSITY · PI TREGGIARI, MIRIAM · 2019 to 2022
$3.0M
Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - Prevent 2 StudyR61HL138650 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI AZIZ, MICHAEL, TREGGIARI, MIRIAM · 2018 to 2018
$657k
NHLBI NIH HHS R33 HL138650NHLBI NIH HHS R61 HL138650
6 · The paper itself

Abstract

backgroundEndotracheal tubes with subglottic ports and a polyurethane cuff are recommended for reducing microaspiration in patients who are ventilated. However, their long-term safety and efficacy after emergency intubation are uncertain.

methodsIn this randomised controlled phase 2 trial conducted at two single centres (Oregon Health and Science University [OHSU, Portland, OR, USA] and Yale New Haven Hospital [YNHH, New Haven, CT, USA]), all patients aged 18 years or older requiring endotracheal intubation either in the emergency department or elsewhere in hospital for acute respiratory distress or failure were randomly assigned to receive a polyurethane-cuffed endotracheal tube with subglottic suction (PU-EVAC) or a polyvinylchloride-cuffed endotracheal tube (PVC). Individuals who were electively intubated in the operating room and protected populations (children [aged younger than 18 years], pregnant women, and prisoners) were ineligible to participate. Patients were randomised 1:1 into the two treatment arms using a fair coin randomisation scheme. Patients assigned to the PVC group were treated according to usual care, and patients assigned to the PU-EVAC group received continuous subglottic suctioning until removal of the endotracheal tube. The coprimary endpoints at 6 months were laryngeal injury, quality of life (Short Form-36 [SF-36] physical component summary [PCS] and mental component summary [MCS] scores), and cognitive function. Secondary endpoints were infection-related ventilator-associated complications (IVAC) and possible ventilator-associated pneumonia (VAP). This trial is registered at ClinicalTrials.gov (NCT03705286) and is now completed.

findingsBetween May 6, 2019, and July 31, 2019 (Oregon Health and Science University), and Sept 29, 2020, to Feb 11, 2022 (Yale New Haven Hospital), 1074 adult patients were enrolled and 1068 were randomly assigned to either the PVC (n=533) or the PU-EVAC (n=535) endotracheal tube group. Participants had a mean age at intubation of 62·9 years (SD 15·7), were mostly male (671 [63%] of 1068), and mostly White (718 [67%]). IVAC occurred in 43 (8%) of 535 patients in the PU-EVAC group and in 33 (6%) of 533 patients in the PVC group (risk difference 0·02 [95% CI -0·01 to 0·05]); possible VAP occurred in 30 (6%) patients in the PU-EVAC group and 24 (5%) patients in the PVC group (0·01 [-0·02 to 0·04]). At 6-month follow-up, 558 patients had died (274 [51%] in the PU-EVAC group and 284 [53%] in the PVC group). 157 completed the 6-month follow-up visit. Laryngeal injury was reported in 71 (83%) of 86 patients in the PU-EVAC group and in 49 (70%) of 70 patients in the PVC group (0·11 [-0·03 to 0·20]; p=0·098). Mean PCS was 39·97 (SD 10·97) in the PU-EVAC group and 40·49 (11·92) in the PVC group (mean difference -0·52 [95% CI -4·21 to 3·17]; p=0·78) and mean MCS was 45·91 (13·10) in the PU-EVAC group and 48·89 (12·22) in the PVC group (-2·98 [-7·03 to 1·07]; p=0·15). Cognitive impairment was present in 70 (85%) of 82 in the PU-EVAC group and 54 (81%) of 67 patients in the PVC group (risk difference 0·05 [-0·07 to 0·17]; p=0·44).

interpretationThe PU-EVAC did not reduce the incidence of IVAC or possible VAP compared with a standard PVC endotracheal tube with no subglottic drainage. At 6-month follow-up, neither quality of life, cognitive function, nor laryngeal injury differed between groups. However, the small number of survivors who provided information on their physical and mental status limits the conclusions that can be drawn regarding long-term outcome differences.

fundingNational Institutes of Health and National Heart, Lung, and Blood Institute.

Indexed as

Intubation, IntratrachealPolyurethanesAdultAgedEmergency Service, HospitalFemaleGlottisHumansMaleMiddle AgedPneumonia, Ventilator-AssociatedRespiration, ArtificialSuctionTreatment OutcomePolyurethanes

Identifiers

PMID41319662
PMCPMC12858053

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.