Evidence map›Paper›PMID 34770264›Full record

ArticleSensors (Basel, Switzerland)2021

Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial.

Lorenzo Cortese, Marta Zanoletti, Umut Karadeniz, Marco Pagliazzi, M Atif Yaqub, David R Busch, Jaume Mesquida, Turgut Durduran

Abstract read
In one paragraph

Article in Sensors (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

8 authors.

Lorenzo CorteseICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.ORCID 0000-0001-9258-0863
Marta ZanolettiICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
Umut KaradenizICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
Marco PagliazziICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
M Atif YaqubICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
David R BuschDepartment of Anesthesiology and Pain Management and Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.ORCID 0000-0002-9488-944X
Jaume MesquidaÀrea de Crítics, Parc Taulí Hospital Universitari, 08208 Sabadell, Spain.
Turgut DurduranICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.

Funding

Agencia Estatal de Investigación PHOTOMETABO, PID2019-106481RB-C31/10.13039/501100011033Ajuntament de Barcelona xEuropean Commission Horizon 2020 LUCA no. 688303, VASCOVID no. 101016087, TinyBrains no. 101017113FEDER EC xFundaciò CELLEX Barcelona xFundació Mir-Puig xGeneralitat de Catalunya CERCA, AGAUR-2017-SGR-1380, RIS3CAT-001-P-001682 CECHLASERLAB-EUROPE V EC H2020 no. 871124Obra social ``la Caixa'' Foundation LlumMedBcnSevero Ochoa Programme for Centres of Excellence in R\&D CEX2019-000910-S
6 · The paper itself

Abstract

Despite the wide range of clinical and research applications, the reliability of the absolute oxygenation measurements of continuous wave near-infrared spectroscopy sensors is often questioned, partially due to issues of standardization. In this study, we have compared the performances of 13 units of a continuous wave near-infrared spectroscopy device (PortaMon, Artinis Medical Systems, NL) to test their suitability for being used in the HEMOCOVID-19 clinical trial in 10 medical centers around the world. Detailed phantom and in vivo tests were employed to measure the precision and reproducibility of measurements of local blood oxygen saturation and total hemoglobin concentration under different conditions: for different devices used, different operators, for probe repositioning over the same location, and over time (hours/days/months). We have detected systematic differences between devices when measuring phantoms (inter-device variability, <4%), which were larger than the intra-device variability (<1%). This intrinsic variability is in addition to the variability during in vivo measurements on the forearm muscle resulting from errors in probe positioning and intrinsic physiological noise (<9%), which was also larger than the inter-device differences (<3%) during the same test. Lastly, we have tested the reproducibility of the protocol of the HEMOCOVID-19 clinical trial; that is, forearm muscle oxygenation monitoring during vascular occlusion tests over days. Overall, our conclusion is that these devices can be used in multi-center trials but care must be taken to characterize, follow-up, and statistically account for inter-device variability.

Indexed as

OximetrySpectroscopy, Near-InfraredOxygenOxygen ConsumptionReproducibility of ResultsOxygencontinuous wave near-infrared spectroscopylight propagation in tissuelocal tissue oxygenationmedical opticsmulti-center clinical trialvascular occlusion test

Identifiers

PMID34770264
PMCPMC8587042

What OpenQuestion holds

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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.