Evidence map›Paper›PMID 31238794›Full record

ArticlePerfusion2020

Selective brain hypothermia: feasibility and safety study of a novel method in five patients.

Seyed Mohammad Seyedsaadat, Silvana F Marasco, David J Daly, Robin McEgan, James Anderson, Seth Rodgers, Thomas Kreck, Ramanathan Kadirvel, David F Kallmes

Open access · hybridAbstract readCase Reports
PubMed Full text at PMC Publisher
In one paragraph

Article in Perfusion, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 27% 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

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Selective intra-arterial brain cooling improves long-term outcomes in a non-human primate model of embolic stroke: Efficacy depending on reperfusion status.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2020
    Article
  4. Article
  5. Article
  6. Review
  7. 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

9 authors at 2 institutions in 2 countries.

Seyed Mohammad SeyedsaadatDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-8219-6144
Silvana F MarascoDepartment of Cardiothoracic Surgery, The Alfred Hospital, Melbourne, VIC, Australia.
David J DalyDepartment of Anaesthesiology & Perioperative Medicine, The Alfred Hospital, Melbourne, VIC, Australia.
Robin McEganDepartment of Perfusion, The Alfred Hospital, Melbourne, VIC, Australia.
James AndersonDepartment of Perfusion, The Alfred Hospital, Melbourne, VIC, Australia.
Seth RodgersNeuroSave, Inc., San Francisco, CA, USA.
Thomas KreckNeuroSave, Inc., San Francisco, CA, USA.
Ramanathan KadirvelDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
David F KallmesDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
The Alfred Hospital · AUMayo Clinic in Arizona · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectiveReduction of brain temperature remains the most common method of neuroprotection against ischemic injury employed during cardiac surgery. However, cooling delivered via the cardiopulmonary bypass circuit is brief and cooling the body core along with the brain has been associated with a variety of unwanted effects. This study investigated the feasibility and safety of a novel selective brain cooling approach to induce rapid, brain-targeted hypothermia independent of the cardiopulmonary bypass circuit.

methodsThis first-in-human feasibility study enrolled five adults undergoing aortic valve replacement with cardiopulmonary bypass support. During surgery, the NeuroSave system circulated chilled saline within the pharynx and upper esophagus. Brain and body core temperature were continuously monitored. Adverse effects, cardiopulmonary function, and device function were noted.

resultsPatient 1 received cooling fluid for an insignificant period, and Patients 2-5 successfully underwent the cooling procedure using the NeuroSave system for 56-89 minutes. Cooling fluid was 12°C for Patients 1-3, 6°C for Patient 4, and 2°C for Patient 5. There were no NeuroSave-related adverse events and no alterations in cardiopulmonary function during NeuroSave use. Brain temperature decreased by 3°C within 15 minutes and remained at least 3.5°C colder than the body core. During a brief episode of hypotension in one patient, the brain cooled an additional 4°C in 2 minutes, briefly reaching 27.4°C.

conclusionThe NeuroSave system can induce rapid brain-targeted hypothermia and simultaneously maintain a favorable body-brain temperature gradient, even during hypotension. Further studies are required to evaluate the function of the system during longer periods of use.

Indexed as

AgedAged, 80 and overBrainBrain InjuriesFeasibility StudiesFemaleHumansHypothermia, InducedMaleMiddle AgedProspective Studiescardiac surgical procedurescirculatory arrestheart arrestneuroprotectionstroketherapeutic hypothermia

Identifiers

PMID31238794
PMCPMC7016355
OpenAlexW2955286986

What OpenQuestion holds

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LicenceCC BY-NC
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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.