Evidence map›Paper›PMID 38994344›Full record

ArticleFrontiers in medicine2024

Calibration trial of an innovative medical device (

Mathieu Bellal, Julien Lelandais, Thomas Chabin, Aurélie Heudron, Thomas Gourmelon, Pierrick Bauduin, Pierre Cuchet, Cédric Daubin, Célia De Carvalho Ribeiro, Augustin Delcampe and 11 more

Abstract read
In one paragraph

Article in Frontiers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

21 authors.

Mathieu BellalDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Julien LelandaisNormandie Univ., UNICAEN, INSERM UMRS U1237 PhIND, Caen, France.
Thomas ChabinSamdoc Medical Technologies Company, Caen, France.
Aurélie HeudronSamdoc Medical Technologies Company, Caen, France.
Thomas GourmelonSamdoc Medical Technologies Company, Caen, France.
Pierrick BauduinDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Pierre CuchetDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Cédric DaubinDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Célia De Carvalho RibeiroDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Augustin DelcampeDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Suzanne GoursaudDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Aurélie JoretDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Martin MombrunDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Xavier ValetteDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.
Damiano CerasuoloDepartment of Methodology and Statistics, Caen University Hospital, Caen, France.
Rémy MorelloDepartment of Methodology and Statistics, Caen University Hospital, Caen, France.
Patrick MordelDepartment of Clinical Research, Caen University Hospital, Caen, France.
Fabien ChaillotDepartment of Clinical Research, Caen University Hospital, Caen, France.
Jean Jacques DutheilDepartment of Clinical Research, Caen University Hospital, Caen, France.
Denis VivienNormandie Univ., UNICAEN, INSERM UMRS U1237 PhIND, Caen, France.
Damien Du CheyronDepartment of Medical Intensive Care, Caen University Hospital, Caen, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pain management is an essential and complex issue for non-communicative patients undergoing sedation in the intensive care unit (ICU). The Behavioral Pain Scale (BPS), although not perfect for assessing behavioral pain, is the gold standard based partly on clinical facial expression. Methods: In this prospective pilot study, we recorded the facial expressions of critically ill patients in the medical ICU of Caen University Hospital using the iPhone and Smart Motion Tracking System (SMTS) software with the Facial Action Coding System (FACS) to measure human facial expressions metrically during sedation weaning. Analyses were recorded continuously, and BPS scores were collected hourly over two 8 h periods per day for 3 consecutive days. For this first stage, calibration of the innovative Results: Thirty participants were enrolled between March and July 2022. To assess the acute severity of illness, the Sequential Organ Failure Assessment (SOFA) and the Simplified Acute Physiology Score (SAPS II) were recorded on ICU admission and were 9 and 47, respectively. All participants had deep sedation, assessed by a Richmond Agitation and Sedation scale (RASS) score of less than or equal to -4 at the time of inclusion. One thousand and six BPS recordings were obtained, and 130 recordings were retained for final calibration: 108 BPS recordings corresponding to the absence of pain and 22 BPS recordings corresponding to the presence of pain. Due to the small size of the dataset, a leave-one-subject-out cross-validation (LOSO-CV) strategy was performed, and the training results obtained the receiver operating characteristic (ROC) curve with an area under the curve (AUC) of 0.792. This model has a sensitivity of 81.8% and a specificity of 72.2%. Conclusion: This pilot study calibrated the

Indexed as

artificial intelligenceBehavioral Pain Scalecritically ill patientsfacial expressionpain

Identifiers

PMID38994344
PMCPMC11236545

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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.