Evidence map›Paper›PMID 29641221›Full record

Trial reportAmerican journal of respiratory and critical care medicine2018

Airway Pressure Release Ventilation in Pediatric Acute Respiratory Distress Syndrome. A Randomized Controlled Trial.

Saptharishi Lalgudi Ganesan, Muralidharan Jayashree, Sunit Chandra Singhi, Arun Bansal

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in American journal of respiratory and critical care medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02167698 (A Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
9.0field-weighted citation impact, top 2% 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.

NCT02167698 naterminatednot on this map

A Parallel-arm, Single Blind Randomised Controlled Trial Comparing 'AIRWAY PRESSURE RELEASE VENTILATION' and 'LOW-TIDAL VOLUME VENTILATION' in Children With Acute Respiratory Distress Syndrome

TypeinterventionalSponsorPost Graduate Institute of Medical Education and Research, ChandigarhRan2014 to 2016Enrolled52ConditionsAcute Respiratory Distress Syndrome (ARDS)ArmsAirway Pressure Release Ventilation (APRV), Low-tidal volume ventilation, Methylprednisolone, Restrictive fluid therapy, sedo-analgesia titration
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Invasive Mechanical Ventilation.Critical care clinics · 2024
    Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. ARDS Clinical Practice Guideline 2021.Journal of intensive care · 2022
    Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Myorelaxants in ARDS patients.Intensive care medicine · 2020
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Saptharishi Lalgudi Ganesan1 Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and.ORCID 0000-0002-2599-9119
Muralidharan Jayashree1 Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and.ORCID 0000-0002-6149-1355
Sunit Chandra Singhi1 Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and.ORCID 0000-0003-2811-2859
Arun Bansal1 Division of Pediatric Critical Care, Department of Pediatrics, Advanced Pediatrics Center, Post Graduate Institute of Medical Education and Research, Chandigarh, India; and.ORCID 0000-0001-6212-6889
Post Graduate Institute of Medical Education and Research · INMedanta The Medicity · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleAlthough case series describe benefits of airway pressure release ventilation (APRV), this mode of ventilation has not been evaluated against the conventional low-tidal volume ventilation (LoTV) in children with acute respiratory distress syndrome (ARDS).

objectivesTo compare the effect of APRV and conventional LoTV on ventilator-free days in children with ARDS.

methodsThis open-label, parallel-design randomized controlled trial was conducted in a 15-bed ICU. Children aged 1 month to 12 years satisfying the modified Berlin definition were included. We excluded children with air leaks, increased intracranial pressure, poor spontaneous breathing efforts, chronic lung disease, and beyond 24 hours of ARDS diagnosis or 72 hours of ventilation. Children were randomized using unstratified, variable-sized block technique. A priori interim analysis was planned at 50% enrollment. All enrolled children were followed up until 180 days after enrollment or death, whichever was earlier. MEASUREMENTS AND MAIN

resultsThe trial was terminated after 50% enrollment (52 children) when analysis revealed higher mortality in the intervention arm. Ventilator-free days were statistically similar in both arms (P = 0.23). The 28-day all-cause mortality was 53.8% in APRV as compared with 26.9% among control subjects (risk ratio, 2.0; 95% confidence interval, 0.97-4.1; Fisher exact P = 0.089). The multivariate-adjusted risk ratio of death for APRV compared with LoTV was 2.02 (95% confidence interval, 0.99-4.12; P = 0.05). Higher mean airway pressures, greater spontaneous breathing, and early improvement in oxygenation were seen in the intervention arm.

conclusionsAPRV, as a primary ventilation strategy in children with ARDS, was associated with a trend toward higher mortality compared with the conventional LoTV. Limitations should be considered while interpreting these results. Clinical trial registered with www.clinicaltrials.gov (NCT02167698) and Clinical Trials Registry of India (CTRI/2014/06/004677).

Indexed as

Early Termination of Clinical TrialsChildChild, PreschoolContinuous Positive Airway PressureFemaleHumansInfantLungMaleRespiratory Distress Syndromelung injurymechanical ventilationpneumoniarandomized controlled trialrespiratory failure

Identifiers

PMID29641221
OpenAlexW2796588153

What OpenQuestion 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 OpenQuestion graph.