Evidence map›Paper›PMID 39323600›Full record

ArticleJournal of the Intensive Care Society2024

Phase I pilot safety and feasibility of a novel restraint device for critically ill patients requiring mechanical ventilation.

Biren B Kamdar, Janelle M Fine, Marie T Pavini, Sara S Ardren, Stephanie Burns, Jason Ht Bates, Ryan S McGinnis, Vinciya Pandian, Benjamin H Lin, Dale M Needham and 1 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the Intensive Care Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

11 authors.

Biren B KamdarDivision of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego School of Medicine, La Jolla, CA, USA.ORCID https://orcid.org/0000-0002-9245-6229
Janelle M FineDivision of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego School of Medicine, La Jolla, CA, USA.ORCID https://orcid.org/0000-0002-6800-4222
Marie T PaviniHealthy Design Ltd. Co., Rutland, VT, USA.
Sara S ArdrenPulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA.
Stephanie BurnsPulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA.
Jason Ht BatesPulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA.
Ryan S McGinnisDepartment of Electrical and Biomedical Engineering, University of Vermont, Burlington, VT, USA.
Vinciya PandianDepartment of Nursing Faculty, Johns Hopkins University School of Nursing, Baltimore, MD, USA.
Benjamin H LinDepartment of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Dale M NeedhamOutcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD, USA.
Renee D StapletonPulmonary and Critical Care Medicine, University of Vermont Larner College of Medicine, Burlington, VT, USA.

Funding

Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive ImpairmentR42AG059451 · NIA · HEALTHY DESIGN, LTD. CO. · PI NEEDHAM, DALE MURRAY, STAPLETON, RENEE D · 2018 to 2020
$2.3M
Multicomponent intervention to improve delirium and sleep-wake rhythms in older ICU patientsK76AG059936 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KAMDAR, BIREN BHARAT · 2018 to 2022
$1.4M
NIA NIH HHS K76 AG059936NIA NIH HHS R42 AG059451
6 · The paper itself

Abstract

Background: Mechanically ventilated Intensive Care Unit (ICU) patients often require wrist restraints, contributing to immobility and agitation, over-sedation, and delirium. The Objective: This National Institutes of Health Small Business Technology Transfer (STTR) Program Grant-funded single-site Phase I feasibility study evaluated Methods: In two academic ICUs, mechanically ventilated adults ⩾25 years old who were non-comatose, required restraints and had an expected stay of ⩾2 days were enrolled to wear Results: Eight patients were enrolled; one no longer required restraints at initiation, yielding seven subjects (median [interquartile range (IQR)] age 65 [55, 70] years, 86% men). All seven wore Conclusions: This pilot study provided key safety and feasibility data for a Phase II RCT evaluating

Indexed as

critical illnessdeliriumICUimmobilityPhysical restraint

Identifiers

PMID39323600
PMCPMC11421263

What OpenQuestion holds

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Registered trials

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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.