Evidence map›Paper›PMID 30277890›Full record

Trial reportCritical care medicine2018

Randomized Feasibility Trial of a Low Tidal Volume-Airway Pressure Release Ventilation Protocol Compared With Traditional Airway Pressure Release Ventilation and Volume Control Ventilation Protocols.

Eliotte L Hirshberg, Michael J Lanspa, Juhee Peterson, Lori Carpenter, Emily L Wilson, Samuel M Brown, Nathan C Dean, James Orme, Colin K Grissom

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.7field-weighted citation impact, top 6% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Invasive Mechanical Ventilation.Critical care clinics · 2024
    Review
  9. Review
  10. Black representation in critical care randomized controlled trials: a meta-epidemiological study.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2023
    Review
  11. Article
  12. Review
  13. Article
  14. Comparison of Ventilator-free Days at 14 and 28 days as a Clinical Trial Outcome in Low- and Middle-income Countries.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2020
    Article
  15. The acute respiratory distress syndrome.Proceedings (Baylor University. Medical Center) · 2020
    Article
  16. Review
  17. Review
  18. Article
  19. The time-controlled adaptive ventilation protocol: mechanistic approach to reducing ventilator-induced lung injury.European respiratory review : an official journal of the European Respiratory Society · 2019
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Eliotte L HirshbergCenter for Humanizing Critical Care, Intermountain Healthcare, Murray, UT.
Michael J LanspaDivision of Pulmonary and Critical Care, Department of Medicine, University of Utah, Salt Lake City, UT.
Juhee PetersonPulmonary Division, Intermountain Medical Center, Murray, UT.
Lori CarpenterPulmonary Division, Intermountain Medical Center, Murray, UT.
Emily L WilsonCenter for Humanizing Critical Care, Intermountain Healthcare, Murray, UT.
Samuel M BrownCenter for Humanizing Critical Care, Intermountain Healthcare, Murray, UT.
Nathan C DeanDivision of Pulmonary and Critical Care, Department of Medicine, University of Utah, Salt Lake City, UT.
James OrmeCenter for Humanizing Critical Care, Intermountain Healthcare, Murray, UT.
Colin K GrissomDivision of Pulmonary and Critical Care, Department of Medicine, University of Utah, Salt Lake City, UT.
University of Utah · USIntermountain Healthcare · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesLow tidal volume (= tidal volume ≤ 6 mL/kg, predicted body weight) ventilation using volume control benefits patients with acute respiratory distress syndrome. Airway pressure release ventilation is an alternative to low tidal volume-volume control ventilation, but the release breaths generated are variable and can exceed tidal volume breaths of low tidal volume-volume control. We evaluate the application of a low tidal volume-compatible airway pressure release ventilation protocol that manages release volumes on both clinical and feasibility endpoints.

designWe designed a prospective randomized trial in patients with acute hypoxemic respiratory failure. We randomized patients to low tidal volume-volume control, low tidal volume-airway pressure release ventilation, and traditional airway pressure release ventilation with a planned enrollment of 246 patients. The study was stopped early because of low enrollment and inability to consistently achieve tidal volumes less than 6.5 mL/kg in the low tidal volume-airway pressure release ventilation arm. Although the primary clinical study endpoint was PaO2/FIO2 on study day 3, we highlight the feasibility outcomes related to tidal volumes in both arms.

settingFour Intermountain Healthcare tertiary ICUs. PATIENTS: Adult ICU patients with hypoxemic respiratory failure anticipated to require prolonged mechanical ventilation.

interventionsLow tidal volume-volume control, airway pressure release ventilation, and low tidal volume-airway pressure release ventilation. MEASUREMENTS AND MAIN

resultsWe observed wide variability and higher tidal (release for airway pressure release ventilation) volumes in both airway pressure release ventilation (8.6 mL/kg; 95% CI, 7.8-9.6) and low tidal volume-airway pressure release ventilation (8.0; 95% CI, 7.3-8.9) than volume control (6.8; 95% CI, 6.2-7.5; p = 0.005) with no difference between airway pressure release ventilation and low tidal volume-airway pressure release ventilation (p = 0.58). Recognizing the limitations of small sample size, we observed no difference in 52 patients in day 3 PaO2/ FIO2 (p = 0.92). We also observed no significant difference between arms in sedation, vasoactive medications, or occurrence of pneumothorax.

conclusionsAirway pressure release ventilation resulted in release volumes often exceeding 12 mL/kg despite a protocol designed to target low tidal volume ventilation. Current airway pressure release ventilation protocols are unable to achieve consistent and reproducible delivery of low tidal volume ventilation goals. A large-scale efficacy trial of low tidal volume-airway pressure release ventilation is not feasible at this time in the absence of an explicit, generalizable, and reproducible low tidal volume-airway pressure release ventilation protocol.

Indexed as

Hospital MortalityAdultAgedClinical ProtocolsContinuous Positive Airway PressureFeasibility StudiesFemaleHumansLength of StayMaleMiddle AgedProspective StudiesRespiratory InsufficiencyTidal Volume

Identifiers

PMID30277890
PMCPMC6250244
OpenAlexW2895035837

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.