Evidence map›Paper›PMID 41397749›Full record

ArticleBMJ open2025

Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol.

Jacqueline M Kruser, Douglas A Wiegmann, Nandita R Nadig, Katharine E Secunda, Bret M Hanlon, Joy X Moy, Arsalan Ahmad, Emily G Campbell, Helen K Donnelly, Francisco J Martinez and 11 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06042621 (Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06042621 enrolling by invitationnot on this map

Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure (The TIME Study): A Mixed Methods Observational Study

TypeobservationalSponsorUniversity of Wisconsin, MadisonRan2024 to 2028Enrolled7,818ConditionsAcute Respiratory Failure, Mechanical Ventilation, Life-Supporting Treatments, Communication
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

21 authors.

Jacqueline M KruserDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA jkruser@wisc.edu.ORCID http://orcid.org/0000-0003-3258-1869
Douglas A WiegmannDepartment of Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Nandita R NadigDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Katharine E SecundaDepartment of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Bret M HanlonDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID http://orcid.org/0000-0002-4517-1204
Joy X MoyDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Arsalan AhmadDepartment of Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Emily G CampbellPalliative and Advanced Illness Research (PAIR) Centre, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Helen K DonnellyDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Francisco J MartinezDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Madison PolleyDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Cemre OrhanDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Erin KorthDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Lily N StalterDepartment of Surgery, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID http://orcid.org/0000-0002-9226-1667
Timothy J RoweDepartment of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Andrew L WuDepartment of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
Elizabeth M VigliantiDepartment of Internal Medicine, University of Michigan-Ann Arbor, Ann Arbor, Michigan, USA.ORCID http://orcid.org/0000-0002-7439-6322
Ella C EisingerDepartment of Medical Ethics and Healthy Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Oliver NguyenDepartment of Industrial and Systems Engineering, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID http://orcid.org/0000-0003-2852-7106
Scott D HalpernDepartment of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Justin T ClappDepartment of Medical Ethics and Healthy Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

Funding

Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure: A Mixed Methods Observational StudyR01HL168474 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI Jacqueline Marie Kruser · 2023 to 2026
$2.7M
CHANGE OF GRANTEE INSTITUTION K23 HL146890 A Systems Approach to Align ICU Care with Patient Treatment GoalsK23HL146890 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI KRUSER, JACQUELINE MARIE · 2019 to 2023
$877k
NHLBI NIH HHS K23 HL146890NHLBI NIH HHS R01 HL168474
6 · The paper itself

Abstract

introductionThe 'time-limited trial' for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient's response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery. METHODS AND ANALYSIS: We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials' conceptual formulation and their heterogeneous, real-world use. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public. TRIAL REGISTRATION NUMBER: NCT06042621.

Indexed as

Critical CareRespiration, ArtificialRespiratory InsufficiencyAnthropology, CulturalHumansIntensive Care UnitsMulticenter Studies as TopicObservational Studies as TopicResearch DesignTime FactorsAdult intensive & critical careETHICS (see Medical Ethics)PALLIATIVE CAREQUALITATIVE RESEARCH

Identifiers

PMID41397749
PMCPMC12706242

What OpenQuestion holds

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LicenceCC BY-NC
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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 OpenQuestion graph.