Cranial NeurosurgeryHERO-PACUNCT07443072
Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery
An observational study of Cranial Neurosurgery, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Neurosurgery
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective Cranial Neruosurgical Patients with planned extubation in the Post-Anesthesia Care Unit (PACU)
Who may be able to join
- Adult patients (≥18 years) scheduled for elective cranial neurosurgery.
- Planned extubation in the PACU after surgery.
- Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).
- Written informed consent signed preoperatively.
Who cannot join
- Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence.
- Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure).
- Preoperative conditions associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative/hypnotic overdose).
- Intraoperative or immediate postoperative events necessitating continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest).
- Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter).
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
Andrea Gentile, MD, + 39 02.2394, andrea.gentile@istituto-besta.it
Marco Gemma, MD, marco.gemma@istituto-besta.it
About this study
Official title: Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery - A Prospective Observational Study in the Post-Anesthesia Care Unit
Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Heart rate variability (HRV) and processed electroencephalography (pEEG) may offer complementary markers of autonomic and cortical function, with potential to improve early detection of complications and guide individualized care.
Read the detailed description
Patients undergoing cranial neurosurgery face a particularly vulnerable postoperative course. The immediate hours after surgery represent a high-risk window, as the transition from anesthesia to recovery is marked by abrupt physiological shifts and the potential for neurological or systemic instability. As patients transition from deep anesthesia to consciousness, dynamic fluctuations in autonomic tone and cortical activity reflect the brain's ability to recover from surgical and anesthetic stress. Smooth emergence and extubation are therefore essential: coughing, hypertension, or surges in intracranial pressure (ICP) can endanger hemostasis and compromise brain protection. Most serious complications-such as intracranial bleeding, cerebral edema, ischemia, hydrocephalus, or herniation-tend to arise within the first hours after surgery.
The Post Anesthesia Care Unit (PACU) constitutes a important window of observation. At this critical phase many strategies have been developed to protect the brain from complication triggering events. For example, remifentanil infusion-whether manual or target-controlled at effect-site concentrations, like adopted at our institution, titrated to suppress airway reflexes and blunt cardiovascular responses-have been shown to promote safe and controlled awakening while preserving prompt neurological evaluation(1-6), facilitating the identification of surgical from anesthetic causes of delayed recovery. Any unrecognized or delayed deterioration early after surgery may herald potentially warning signs, highlighting the need for accurate, physiology-based monitoring to support timely detection and intervention.
Standard monitoring-focused largely on vital signs-offers limited insight into the underlying brain and autonomic processes that govern recovery. Heat rate variability (HRV) and processed electroencephalography (pEEG) features, may provide novel means to characterize patient vulnerability in the PACU, improving risk stratification and guiding individualized perioperative care.
- Conditions
- Cranial Neurosurgery
- Keywords
- HRV, heart rate variability, EEG, electroencephalography, EEG patterns, EEG signatures, pEEG, processed EEG, Neurosurgery, Monitoring, PACU, Post Anesthesia Care Unit, Autonomous Nervous System, Cortical Function, Outcome after Neurosurgery, Post Operative Period, Post Operative Monitoring, Post Operative Outcome, Anesthesia, Emergence
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal trajectories of HRV and pEEG after Neurosurgery in the PACU
Quantitative assessment of autonomic and cortical recovery during the entire period of PACU staying until 120 minutes after extubation or PACU discharge
- Heart Rate Variability (HRV) parameters derived from continuous ECG recording, including: Time-domain indices: RMSSD (ms) SDNN (ms) Frequency-domain indices: LF power (ms²) HF power (ms²) LF/HF ratio (dimensionless) HRV will be calculated from high-resolution ECG signals using validated software following international standards (Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology).
- Processed EEG (pEEG) parameters obtained from a commercial depth-of-anesthesia monitor, including:
Processed EEG index value (dimensionless scale, 0-100) Spectral edge frequency (Hz) Relative alpha and delta power (% of total EEG power) Measurements will be extracted in predefined 5-minute epochs during of PACU monitoring
Measured: 1 year
Secondary outcomes (4)
Correlation Between HRV/pEEG Parameters in PACU and Incidence of Early Postoperative Complications Within 48 Hours
Association between HRV and pEEG parameters (RMSSD, SDNN, LF/HF ratio, pEEG index, spectral edge frequency) measured during the first 60 minutes in PACU and the occurrence of predefined postoperative complications within 48 hours.
Postoperative complications will include:
- Intracranial hemorrhage
- Cerebral edema
- Hydrocephalus
- Ischemic events
- Delirium
- Reintubation
- Unplanned ICU admission Complications will be recorded as a binary variable (presence/absence).
The strength of association will be quantified using:
- Odds Ratios (OR) from multivariable logistic regression models
- Area Under the Receiver Operating Characteristic Curve (AUC)
Unit of Measure:
- Incidence (% of patients with complication)
- Odds ratio (dimensionless)
- AUC (0-1 scale)
Measured: 48 hours after surgery
Correlation Between HRV/pEEG Parameters and Perioperative Drug Exposure
Correlation between HRV/pEEG parameters measured in PACU and intraoperative anesthetic and opioid exposure including:
- Total propofol dose (mg)
- Total remifentanil dose (µg)
- Effect-site concentration at end of surgery (µg/mL or ng/mL)
The relationship will be quantified using:
- Pearson or Spearman correlation coefficients (r)
- Multivariable linear regression coefficients (β)
Unit of Measure:
- Drug dose (mg, µg)
- Effect-site concentration (µg/mL or ng/mL)
- Correlation coefficient (r, -1 to +1)
Measured: Intraoperative period
Correlation Between HRV/pEEG Parameters and Perioperative Clinical Variables
Correlation between PACU HRV/pEEG parameters and:
- Duration of surgery (minutes)
- Intraoperative hypotension duration (minutes below MAP threshold)
- Estimated blood loss (mL)
- ASA physical status classification
Association will be assessed using:
- Pearson/Spearman correlation
- Multivariable regression models
Unit of Measure:
- Minutes
- mL
- ASA class (categorical scale)
- Correlation coefficient (r)
Measured: Intraoperative period
Feasibility and Data Quality of HRV and pEEG Monitoring in PACU
Assessment of feasibility and signal quality of ECG and pEEG recordings during PACU monitoring, including:
- Percentage of analyzable ECG epochs (%)
- Percentage of analyzable EEG epochs (%)
- Artifact burden (% of recording time excluded)
Unit of Measure:
Percentage (%)
Measured: First 60 minutes of PACU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start5 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Cranial NeurosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443072
- Sponsor's protocol ID
- HERO-PACU
- Acronym
- HERO-PACU
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marino L, Badenes R, Bilotta F. Heart Rate Variability for Outcome Prediction in Intracerebral and Subarachnoid Hemorrhage: A Systematic Review. J Clin Med. 2023 Jun 28;12(13):4355. doi: 10.3390/jcm12134355.
PubMed 37445389Frandsen MN, Mehlsen J, Foss NB, Kehlet H. Preoperative heart rate variability as a predictor of perioperative outcomes: a systematic review without meta-analysis. J Clin Monit Comput. 2022 Aug;36(4):947-960. doi: 10.1007/s10877-022-00819-z. Epub 2022 Jan 29.
PubMed 35092527Winchell RJ, Hoyt DB. Analysis of heart-rate variability: a noninvasive predictor of death and poor outcome in patients with severe head injury. J Trauma. 1997 Dec;43(6):927-33. doi: 10.1097/00005373-199712000-00010.
PubMed 9420107Liu X, Wan H, Wang H, Zhang G, Zhong Q, Duan X. Correlation between heart rate variability and perioperative neurocognitive disorders in patients undergoing non-cardiac surgery: A retrospective cohort study. PLoS One. 2024 Apr 2;19(4):e0297337. doi: 10.1371/journal.pone.0297337. eCollection 2024.
PubMed 38564647Satomoto M. Predicting Postoperative Emergence Delirium From the Heart Rate Variability of Patients Undergoing Elective Cardiac Surgery. Cureus. 2023 Feb 3;15(2):e34613. doi: 10.7759/cureus.34613. eCollection 2023 Feb.
PubMed 36891021Li X, Deng X, Huang Z, Kowark A, Coburn M, Zhang G, Duan X. Relationship between Heart Rate Variability and Postoperative Cognitive Dysfunction in Elderly Patients. Am J Health Behav. 2023 Feb 28;47(1):65-74. doi: 10.5993/AJHB.47.1.8.
PubMed 36945090Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y.
PubMed 35882875Shahiri TS, Richard-Lalonde M, Richebe P, Gelinas C. Exploration of the Nociception Level (NOL) Index for Pain Assessment during Endotracheal Suctioning in Mechanically Ventilated Patients in the Intensive Care Unit: An Observational and Feasibility Study. Pain Manag Nurs. 2020 Oct;21(5):428-434. doi: 10.1016/j.pmn.2020.02.067. Epub 2020 Apr 27.
PubMed 32354616Ushiyama T, Nakatsu T, Yamane S, Tokutake H, Wakabayashi H, Ishimura K, Maeta H. Heart rate variability for evaluating surgical stress and development of postoperative complications. Clin Exp Hypertens. 2008 Jan;30(1):45-55. doi: 10.1080/10641960701813908.
PubMed 18214733Wujtewicz M, Owczuk R. Heart rate variability in anaesthesiology - narrative review. Anaesthesiol Intensive Ther. 2023;55(1):1-8. doi: 10.5114/ait.2023.126309.
PubMed 37306266So V, Balanaser M, Klar G, Leitch J, McGillion M, Devereaux PJ, Arellano R, Parlow J, Gilron I. Scoping review of the association between postsurgical pain and heart rate variability parameters. Pain Rep. 2021 Dec 2;6(4):e977. doi: 10.1097/PR9.0000000000000977. eCollection 2021 Nov-Dec.
PubMed 35155967Wojtanowski A, Hureau M, Jeanne M, Bureau C, Recher M, De Jonckheere J. Heart rate variability as a marker of multiple organ dysfunction syndromes: a systematic review. J Clin Monit Comput. 2025 Aug;39(4):717-729. doi: 10.1007/s10877-025-01296-w. Epub 2025 Apr 21.
PubMed 40259139Liu J, Liu S, Gao L, Li G, Xu J, Sun Y, Wang J, Shi B. Predicting Post-operative Blood Inflammatory Biomarkers Using Pre-operative Heart Rate Variability in Patients With Cervical Cancer. Front Physiol. 2021 Nov 4;12:696208. doi: 10.3389/fphys.2021.696208. eCollection 2021.
PubMed 34803724Huston JM, Tracey KJ. The pulse of inflammation: heart rate variability, the cholinergic anti-inflammatory pathway and implications for therapy. J Intern Med. 2011 Jan;269(1):45-53. doi: 10.1111/j.1365-2796.2010.02321.x.
PubMed 21158977Cooper TM, McKinley PS, Seeman TE, Choo TH, Lee S, Sloan RP. Heart rate variability predicts levels of inflammatory markers: Evidence for the vagal anti-inflammatory pathway. Brain Behav Immun. 2015 Oct;49:94-100. doi: 10.1016/j.bbi.2014.12.017. Epub 2014 Dec 22.
PubMed 25541185
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery - A Prospective Observational Study in the Post-Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT07443072
- Acronym / sponsor ID
- HERO-PACU / HERO-PACU
- Conditions
- Cranial Neurosurgery
- Keywords
- HRV, heart rate variability, EEG, electroencephalography, EEG patterns, EEG signatures, pEEG, processed EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Heart rate variability (HRV) and processed electroencephalography (pEEG) may offer complementary markers of autonomic and cortical function, with potential to improve early detection of complications and guide individualized care.
Detailed description
Patients undergoing cranial neurosurgery face a particularly vulnerable postoperative course. The immediate hours after surgery represent a high-risk window, as the transition from anesthesia to recovery is marked by abrupt physiological shifts and the potential for neurological or systemic instability. As patients transition from deep anesthesia to consciousness, dynamic fluctuations in autonomic tone and cortical activity reflect the brain's ability to recover from surgical and anesthetic stress. Smooth emergence and extubation are therefore essential: coughing, hypertension, or surges in intracranial pressure (ICP) can endanger hemostasis and compromise brain protection. Most serious complications-such as intracranial bleeding, cerebral edema, ischemia, hydrocephalus, or herniation-tend to arise within the first hours after surgery.
The Post Anesthesia Care Unit (PACU) constitutes a important window of observation. At this critical phase many strategies have been developed to protect the brain from complication triggering events. For example, remifentanil infusion-whether manual or target-controlled at effect-site concentrations, like adopted at our institution, titrated to suppress airway reflexes and blunt cardiovascular responses-have been shown to promote safe and controlled awakening while preserving prompt neurological evaluation(1-6), facilitating the identification of surgical from anesthetic causes of delayed recovery. Any unrecognized or delayed deterioration early after surgery may herald potentially warning signs, highlighting the need for accurate, physiology-based monitoring to support timely detection and intervention.
Standard monitoring-focused largely on vital signs-offers limited insight into the underlying brain and autonomic processes that govern recovery. Heat rate variability (HRV) and processed electroencephalography (pEEG) features, may provide novel means to characterize patient vulnerability in the PACU, improving risk stratification and guiding individualized perioperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective Cranial Neruosurgical Patients with planned extubation in the Post-Anesthesia Care Unit (PACU)
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) scheduled for elective cranial neurosurgery.
- Planned extubation in the PACU after surgery.
- Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).
- Written informed consent signed preoperatively.
Key exclusion criteria (6 listed)
- Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence.
- Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure).
- Preoperative conditions associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative/hypnotic overdose).
- Intraoperative or immediate postoperative events necessitating continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest).
- Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temporal trajectories of HRV and pEEG after Neurosurgery in the PACU
Time frame: 1 year
Quantitative assessment of autonomic and cortical recovery during the entire period of PACU staying until 120 minutes after extubation or PACU discharge 1. Heart Rate Variability (HRV) parameters derived from continuous ECG recording, including: Time-domain indices: RMSSD (ms) SDNN (ms) Frequency-domain indices: LF power (ms²) HF power (ms²) LF/HF ratio (dimensionless) HRV will be calculated from high-resolution ECG signals using validated software following international standards (Task Force of the European Society of Cardiology and North American Society of Pacing and Electrophysiology). 2. Processed EEG (pEEG) parameters obtained from a commercial depth-of-anesthesia monitor, including: Processed EEG index value (dimensionless scale, 0-100) Spectral edge frequency (Hz) Relative alpha and delta power (% of total EEG power) Measurements will be extracted in predefined 5-minute epochs during of PACU monitoring
4 secondary outcomes
Correlation Between HRV/pEEG Parameters in PACU and Incidence of Early Postoperative Complications Within 48 Hours
Time frame: 48 hours after surgery
Correlation Between HRV/pEEG Parameters and Perioperative Drug Exposure
Time frame: Intraoperative period
Correlation Between HRV/pEEG Parameters and Perioperative Clinical Variables
Time frame: Intraoperative period
Feasibility and Data Quality of HRV and pEEG Monitoring in PACU
Time frame: First 60 minutes of PACU stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 37445389Marino L, Badenes R, Bilotta F. Heart Rate Variability for Outcome Prediction in Intracerebral and Subarachnoid Hemorrhage: A Systematic Review. J Clin Med. 2023 Jun 28;12(13):4355. doi: 10.3390/jcm12134355.
- Background: PubMed 35092527Frandsen MN, Mehlsen J, Foss NB, Kehlet H. Preoperative heart rate variability as a predictor of perioperative outcomes: a systematic review without meta-analysis. J Clin Monit Comput. 2022 Aug;36(4):947-960. doi: 10.1007/s10877-022-00819-z. Epub 2022 Jan 29.
- Background: PubMed 9420107Winchell RJ, Hoyt DB. Analysis of heart-rate variability: a noninvasive predictor of death and poor outcome in patients with severe head injury. J Trauma. 1997 Dec;43(6):927-33. doi: 10.1097/00005373-199712000-00010.
- Background: PubMed 38564647Liu X, Wan H, Wang H, Zhang G, Zhong Q, Duan X. Correlation between heart rate variability and perioperative neurocognitive disorders in patients undergoing non-cardiac surgery: A retrospective cohort study. PLoS One. 2024 Apr 2;19(4):e0297337. doi: 10.1371/journal.pone.0297337. eCollection 2024.
- Background: PubMed 36891021Satomoto M. Predicting Postoperative Emergence Delirium From the Heart Rate Variability of Patients Undergoing Elective Cardiac Surgery. Cureus. 2023 Feb 3;15(2):e34613. doi: 10.7759/cureus.34613. eCollection 2023 Feb.
- Background: PubMed 36945090Li X, Deng X, Huang Z, Kowark A, Coburn M, Zhang G, Duan X. Relationship between Heart Rate Variability and Postoperative Cognitive Dysfunction in Elderly Patients. Am J Health Behav. 2023 Feb 28;47(1):65-74. doi: 10.5993/AJHB.47.1.8.
- Background: PubMed 35882875Perez-Otal B, Aragon-Benedi C, Pascual-Bellosta A, Ortega-Lucea S, Martinez-Ubieto J, Ramirez-Rodriguez JM; Research Group in Anaesthesia, Resuscitation, and Perioperative Medicine of Institute for Health Research Aragon (ISS Aragon). Neuromonitoring depth of anesthesia and its association with postoperative delirium. Sci Rep. 2022 Jul 26;12(1):12703. doi: 10.1038/s41598-022-16466-y.
- Background: PubMed 32354616Shahiri TS, Richard-Lalonde M, Richebe P, Gelinas C. Exploration of the Nociception Level (NOL) Index for Pain Assessment during Endotracheal Suctioning in Mechanically Ventilated Patients in the Intensive Care Unit: An Observational and Feasibility Study. Pain Manag Nurs. 2020 Oct;21(5):428-434. doi: 10.1016/j.pmn.2020.02.067. Epub 2020 Apr 27.
- Background: PubMed 18214733Ushiyama T, Nakatsu T, Yamane S, Tokutake H, Wakabayashi H, Ishimura K, Maeta H. Heart rate variability for evaluating surgical stress and development of postoperative complications. Clin Exp Hypertens. 2008 Jan;30(1):45-55. doi: 10.1080/10641960701813908.
- Background: PubMed 37306266Wujtewicz M, Owczuk R. Heart rate variability in anaesthesiology - narrative review. Anaesthesiol Intensive Ther. 2023;55(1):1-8. doi: 10.5114/ait.2023.126309.
- Background: PubMed 35155967So V, Balanaser M, Klar G, Leitch J, McGillion M, Devereaux PJ, Arellano R, Parlow J, Gilron I. Scoping review of the association between postsurgical pain and heart rate variability parameters. Pain Rep. 2021 Dec 2;6(4):e977. doi: 10.1097/PR9.0000000000000977. eCollection 2021 Nov-Dec.
- Background: PubMed 40259139Wojtanowski A, Hureau M, Jeanne M, Bureau C, Recher M, De Jonckheere J. Heart rate variability as a marker of multiple organ dysfunction syndromes: a systematic review. J Clin Monit Comput. 2025 Aug;39(4):717-729. doi: 10.1007/s10877-025-01296-w. Epub 2025 Apr 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cranial Neurosurgery, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Gentile, MD (+ 39 02.2394, andrea.gentile@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal trajectories of HRV and pEEG after Neurosurgery in the PACU (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07443072, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.