See the published version of this preprint at Systematic Reviews.
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Protocol
Mathias Lühr Hansen
Copenhagen University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1957-7005
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Multiple clinical conditions are associated with cerebral hypoxia/ischaemia and thereby an increased risk of hypoxic-ischaemic brain injury. Cerebral near-infrared spectroscopy monitoring (NIRS) is a tool to monitor brain oxygenation and perfusion, and the clinical uptake of NIRS has expanded over recent years. Specifically, NIRS is used in the perioperative and neonatal, paediatric, and adult intensive care settings. However, the available literature suggests that clinical benefits and harms of cerebral NIRS monitoring are uncertain. As rates of clinically significant hypoxic-ischaemic brain injuries are typically low, it is difficult for randomised clinical trials to capture a sufficiently large number of events to evaluate the clinical effect of cerebral NIRS monitoring, when focusing on specific clinical settings.
Methods
We will conduct a systematic review with meta-analysis and Trial Sequential Analysis to evaluate the benefits and harms of clinical care with cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings. We will only include randomised clinical trials and the primary outcomes are all-cause mortality, moderate or severe persistent cognitive or neurological deficit, and proportion of participants with one or more serious adverse events. The review will be conducted according to the methodology described in The Cochrane Handbook for Systematic Reviews of Interventions, including GRADE. An eight-step procedure by Jakobsen et al. will be used to assess if thresholds for statistical and clinical significance are crossed.
Discussion
As we include trials across multiple clinical settings, there is an increased probability of reaching a sufficient information size. However, heterogeneity between the included trials may impair our ability to interpret results to specific clinical settings. In this situation, we may have to depend on subgroup analyses with inherent increased risks of type I and II errors.
Systematic review registration
This systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) (1,2) on 12th of October 2020.
Keywords
systematic review, cerebral NIRS monitoring, cerebral oxygenation monitoring, hypoxic-ischaemic brain injury, intensive care, anaesthesia, surgery, neonatal intensive care, meta-analysis, trial sequential analysis
This is a list of supplementary files associated with this preprint. Click to download.
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Systematic Reviews.
Version 1
Posted 19 Oct, 2020
No community comments so far
Review #1 received
Received 17 Mar, 2021
Editorial decision: Minor revision
On 17 Mar, 2021
Reviewers invited
Invitations sent on 27 Feb, 2021
Reviewer #1 agreed
On 27 Feb, 2021
Editor assigned
On 25 Feb, 2021
Editor invited
On 25 Feb, 2021
Submission checks complete
On 15 Oct, 2020
First submitted
On 12 Oct, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Systematic Reviews.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Protocol
Mathias Lühr Hansen
Copenhagen University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1957-7005
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Systematic Reviews.
Version 1
Posted 19 Oct, 2020
No community comments so far
Review #1 received
Received 17 Mar, 2021
Editorial decision: Minor revision
On 17 Mar, 2021
Reviewers invited
Invitations sent on 27 Feb, 2021
Reviewer #1 agreed
On 27 Feb, 2021
Editor assigned
On 25 Feb, 2021
Editor invited
On 25 Feb, 2021
Submission checks complete
On 15 Oct, 2020
First submitted
On 12 Oct, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Systematic Reviews.
Background
Multiple clinical conditions are associated with cerebral hypoxia/ischaemia and thereby an increased risk of hypoxic-ischaemic brain injury. Cerebral near-infrared spectroscopy monitoring (NIRS) is a tool to monitor brain oxygenation and perfusion, and the clinical uptake of NIRS has expanded over recent years. Specifically, NIRS is used in the perioperative and neonatal, paediatric, and adult intensive care settings. However, the available literature suggests that clinical benefits and harms of cerebral NIRS monitoring are uncertain. As rates of clinically significant hypoxic-ischaemic brain injuries are typically low, it is difficult for randomised clinical trials to capture a sufficiently large number of events to evaluate the clinical effect of cerebral NIRS monitoring, when focusing on specific clinical settings.
Methods
We will conduct a systematic review with meta-analysis and Trial Sequential Analysis to evaluate the benefits and harms of clinical care with cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings. We will only include randomised clinical trials and the primary outcomes are all-cause mortality, moderate or severe persistent cognitive or neurological deficit, and proportion of participants with one or more serious adverse events. The review will be conducted according to the methodology described in The Cochrane Handbook for Systematic Reviews of Interventions, including GRADE. An eight-step procedure by Jakobsen et al. will be used to assess if thresholds for statistical and clinical significance are crossed.
Discussion
As we include trials across multiple clinical settings, there is an increased probability of reaching a sufficient information size. However, heterogeneity between the included trials may impair our ability to interpret results to specific clinical settings. In this situation, we may have to depend on subgroup analyses with inherent increased risks of type I and II errors.
Systematic review registration
This systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) (1,2) on 12th of October 2020.
This is a list of supplementary files associated with this preprint. Click to download.
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