Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial
Background: Resuscitation guidelines propose a multimodal prognostication strategy algorithm at ≥72 hours after the return of spontaneous circulation to evaluate neurological outcome for unconscious cardiac arrest survivors. Even though guidelines suggest quantitative pupillometry for assessing pupi...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-12-01
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| Series: | Resuscitation Plus |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666520423001182 |
| _version_ | 1797429629527523328 |
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| author | Benjamin Nyholm Johannes Grand Laust Emil Roelsgaard Obling Christian Hassager Jacob Eifer Møller Henrik Schmidt Marwan H. Othman Daniel Kondziella Jesper Kjaergaard |
| author_facet | Benjamin Nyholm Johannes Grand Laust Emil Roelsgaard Obling Christian Hassager Jacob Eifer Møller Henrik Schmidt Marwan H. Othman Daniel Kondziella Jesper Kjaergaard |
| author_sort | Benjamin Nyholm |
| collection | DOAJ |
| description | Background: Resuscitation guidelines propose a multimodal prognostication strategy algorithm at ≥72 hours after the return of spontaneous circulation to evaluate neurological outcome for unconscious cardiac arrest survivors. Even though guidelines suggest quantitative pupillometry for assessing pupillary light reflex, threshold values are not yet validated.This study aims to validate pre-specified thresholds of quantitative pupillometry by quantitatively assessing the percentage reduction of pupillary size (qPLR) <4% and Neurological Pupil index (NPi) ≤2 and in predicting unfavorable neurological outcome. Both as an isolated predictor and combined with guideline-suggested neuron-specific enolase (NSE) threshold >60 μg L−1 in the current prognostication strategy algorithm. Methods: We conduct this pre-planned diagnostic sub-study in the randomized, controlled, multicenter clinical trial “Blood Pressure and Oxygenation Targets after Out-of-Hospital Cardiac Arrest-trial”. Blinded to treating physicians and outcome assessors, measurements of qPLR and NPi are obtained from cardiac arrest survivors at time points (±6 hours) of admission, after 24, 48, and 72 hours, or until the time of awakening or death. Discussion: This study will be the largest prospective study investigating the predictive performance of automated quantitative pupillometry in unconscious patients resuscitated from cardiac arrest. We will test specific threshold values of NPi ≤2 and qPLR <4% to predict unfavorable outcome following cardiac arrest. The validation of pupillometry alone and combined with NSE with the criteria of the current prognostication strategy algorithm will hopefully increase the level of evidence and support clinical neuroprognostication with automated quantitative pupillometry in unconscious post-cardiac arrest patients. Trial registration: Registered March 30, 2017, at ClinicalTrials.gov (Identifier: NCT03141099). |
| first_indexed | 2024-03-09T09:15:53Z |
| format | Article |
| id | doaj.art-7f646c78451d4cca9483319814c4d7a2 |
| institution | Directory Open Access Journal |
| issn | 2666-5204 |
| language | English |
| last_indexed | 2024-03-09T09:15:53Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Resuscitation Plus |
| spelling | doaj.art-7f646c78451d4cca9483319814c4d7a22023-12-02T07:06:54ZengElsevierResuscitation Plus2666-52042023-12-0116100475Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trialBenjamin Nyholm0Johannes Grand1Laust Emil Roelsgaard Obling2Christian Hassager3Jacob Eifer Møller4Henrik Schmidt5Marwan H. Othman6Daniel Kondziella7Jesper Kjaergaard8Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Corresponding author at: Department of Cardiology, The Heart Center, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK2100 Copenhagen East, Denmark.Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Cardiology, Odense University Hospital, 5000 C Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, DenmarkDepartment of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, DenmarkDepartment of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkClinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkBackground: Resuscitation guidelines propose a multimodal prognostication strategy algorithm at ≥72 hours after the return of spontaneous circulation to evaluate neurological outcome for unconscious cardiac arrest survivors. Even though guidelines suggest quantitative pupillometry for assessing pupillary light reflex, threshold values are not yet validated.This study aims to validate pre-specified thresholds of quantitative pupillometry by quantitatively assessing the percentage reduction of pupillary size (qPLR) <4% and Neurological Pupil index (NPi) ≤2 and in predicting unfavorable neurological outcome. Both as an isolated predictor and combined with guideline-suggested neuron-specific enolase (NSE) threshold >60 μg L−1 in the current prognostication strategy algorithm. Methods: We conduct this pre-planned diagnostic sub-study in the randomized, controlled, multicenter clinical trial “Blood Pressure and Oxygenation Targets after Out-of-Hospital Cardiac Arrest-trial”. Blinded to treating physicians and outcome assessors, measurements of qPLR and NPi are obtained from cardiac arrest survivors at time points (±6 hours) of admission, after 24, 48, and 72 hours, or until the time of awakening or death. Discussion: This study will be the largest prospective study investigating the predictive performance of automated quantitative pupillometry in unconscious patients resuscitated from cardiac arrest. We will test specific threshold values of NPi ≤2 and qPLR <4% to predict unfavorable outcome following cardiac arrest. The validation of pupillometry alone and combined with NSE with the criteria of the current prognostication strategy algorithm will hopefully increase the level of evidence and support clinical neuroprognostication with automated quantitative pupillometry in unconscious post-cardiac arrest patients. Trial registration: Registered March 30, 2017, at ClinicalTrials.gov (Identifier: NCT03141099).http://www.sciencedirect.com/science/article/pii/S2666520423001182Cardiac arrestPost resuscitation careGuidelinesQuantitative PupillometryPrognostication |
| spellingShingle | Benjamin Nyholm Johannes Grand Laust Emil Roelsgaard Obling Christian Hassager Jacob Eifer Møller Henrik Schmidt Marwan H. Othman Daniel Kondziella Jesper Kjaergaard Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial Resuscitation Plus Cardiac arrest Post resuscitation care Guidelines Quantitative Pupillometry Prognostication |
| title | Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial |
| title_full | Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial |
| title_fullStr | Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial |
| title_full_unstemmed | Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial |
| title_short | Quantitative pupillometry for neuroprognostication in comatose post-cardiac arrest patients: A protocol for a predefined sub-study of the Blood pressure and Oxygenations Targets after Out-of-Hospital Cardiac Arrest (BOX)-trial |
| title_sort | quantitative pupillometry for neuroprognostication in comatose post cardiac arrest patients a protocol for a predefined sub study of the blood pressure and oxygenations targets after out of hospital cardiac arrest box trial |
| topic | Cardiac arrest Post resuscitation care Guidelines Quantitative Pupillometry Prognostication |
| url | http://www.sciencedirect.com/science/article/pii/S2666520423001182 |
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