Cerebral HypoxiaNCT06306950
Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit.
A study testing Near infrared spectroscopy neuromonitor to prevent cerebral desaturation in people with Cerebral Hypoxia and Severe Traumatic Brain Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebral Hypoxia, Severe Traumatic Brain Injury
- What is being tested?
- Near infrared spectroscopy neuromonitor to prevent cerebral desaturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- age more than 20 years old
- severe traumatic brain injury defined as Glasgow coma scale < 8
Who cannot join
- pregnancy
- infection at the forehead
- status epilepticus
- history of drug addiction
- severe traumatic brain injury combination with metabolic causes
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Phramongkutklao College of Medicine and Hospital
Bangkok, 10400
About this study
Official title: Optimization of Cerebral Oximetry And Avoid Cerebral Deoxygenation In Severe Traumatic Brain Injury.
Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients.
Read the detailed description
We conducted a prospective interventional study. Data from all 80 severe traumatic brain injury patients were randomized to either perioperative cerebral regional oxygen saturation (rSO2) monitoring with an intervention protocol to prevent cerebral desaturation (intervention, n = 40), or underwent blinded rSO2 monitoring (control, n = 40). Predefined clinical outcomes were assessed by a blinded observer. 40 were retrieved on April 1, 2021 to February 28, 2024. Data collection comprised of patients' demographic data, treatment process, and outcomes of treatment was implemented in the intensive care unit. The pre-intervention included all consecutive severe traumatic brain injury patients admitted as participants. After ethic approval in all methods and obtaining written informed consent from the legal relatives, severe traumatic brain injury patients were enrolled on the basis of inclusion criteria of age ≥ 20 years, Patients were recruited from the preoperative clinic in cases of neurosurgery with agreement. Upon arrival in the emergency department, the randomization envelope was opened, and patients were assigned into either active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA). After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors. Once values had stabilized, the screen was electronically blinded, and the time monitoring and baseline parameters were recorded by taking the data frequency of 1 minute, 3 minutes after the start recording. For the intervention group, an alarm threshold at 55% of the resting baseline rSO2 value was established. Continuous rSO2 values were stored on a floppy disk with a 15-second update for the duration of the perioperative period. With the application of the scalp dressing and before leaving the ICU, monitoring was discontinued, and optodes were removed after discharge from the ICU for 10 days.
For all severe traumatic brain injury patients, the best clinical practices aim at maintaining hemoglobin (Hb) levels greater than 7 g/dl, blood glucose within the institutional normal range of 80-180 mg/dl, and mean arterial pressure (MAP) of 65 mmHg in the intensive care unit. In the intervention group, a prioritized management protocol was used to maintain rSO2 values at or above 55% of the baseline threshold. With a decrease in rSO2, the patient's head position was checked to ensure that it had not been rotated or kinked, and the face was observed to detect plethora. If PaCO2 or end-tidal CO2 was below 40 mmHg during positive pressure ventilation, ventilation was reduced to achieve PaCO2 ≥ 40 mmHg. If MAP was < 65 mmHg, 40 μg increments of intravenous norepinephrine were administered to achieve an MAP ≥ 65 mmHg. If the cardiac index was < 2.0 L/m2/min, administration of dobutamine increased to 2.5 L/m2/min. In patients with persistent rSO2 below the treatment threshold, FiO2 was increased. If Hb was below 7 g/dl, a red blood cell transfusion was administered immediately. Cerebral oximetry monitoring was continued after discharge from the intensive care unit for 10 days. To maintain participant blindness, no study group identifiers were included with the patient or in the patients' charts. For neurosurgical intensive care unit postoperatively, all patients were transferred to an autonomous, protocol-given, "closed" neuro-intensive care unit under the exclusion care of an intensive care unit intensivist without direct reference to the attending neurosurgeons or anesthesiologists. Criteria for discharge from the intensive care unit comprised (1) hemodynamic stability defined as absence of vasopressor or inotropic drugs, removal of arterial and pulmonary artery or central venous catheters, and absence of cardiac arrhythmias; (2) post-extubation respiratory parameter adequacy with maintenance of pulse oximetry (SpO2) > 95% with supplemental O2 below 5 L/min; (3) level of consciousness appropriate sufficient to protect their airway; and (4) good kidney function (urinary output ≥ 0.5 mL/kg/hr). Data on ICU admission and discharge times, and use of a vasopressor were obtained from the intensive care unit database.
The sample size was based upon a projected near infrared spectroscopy (NIRS)-derived tissue oxygenation published in Annual Intensive Care 2012 about the correlation between near infrared spectroscopy (NIRS) in anesthesia and intensive care and brain tissue oxygenation and major organ function. As a priority assumption, we hypothesized that a 50% reduction in the incidence of overall complications would be associated with active NIRS cerebral oximetry. Accepting a p-value < 0.05 for statistical significance and a β error of 0.2, we determined that 40 patients in each group were required for this study. The randomization method was done by blinded envelopes assigning treatment allocation and placing them in computer-generated random order, which were written in order to sequentially identify each subject that registered in this protocol and was disclosed in the neurosurgical ICU. Cerebral deoxygenation means a reduction in saturation below 55% of baseline for 1 minute or longer. To minimize the probability of patients reaching these levels, interventions to improve cerebral oxygenation were administered when rSO2 decreased to < 55% of baseline for > 15 s. Mean and minimum values of rSO2. Categorical values are presented as numbers (percentage) and were analyzed using contingency table analysis, Fisher's exact test, χ2, and Wilcoxon's rank sum tests as appropriate. Continuous variables are presented as mean ± SD using an unpaired t-test or ANOVA for analysis, with a p-value < 0.05 required for statistical significance.
80 patients in the ICU were monitored for invasive arterial blood pressure, peripheral O2 saturation (SpO2), and electrocardiograms. Sedative and paralysis agents were given; keep the Richmond Agitation Sedation Scale (RASS) less than -3 and the Bispectral Index (BIS) 40-60 monitoring based on bedside intensivist judgment, including fentanyl, propofol, midazolam, and cisatracurium. Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 ml/kg, a respiratory rate adjusted to maintain normocapnia, an inspired oxygen fraction adjusted to maintain SpO2 above 95%, and an inspiratory/expiratory ratio of 1:2. The inclusion criteria were age more than 20 years old, Severe traumatic brain injury defined as Glasgow coma scale < 8, and the exclusion criteria were patients who had a pregnancy, an infection at the forehead, a status epilepticus, a history of drug addiction, and Severe traumatic brain injury combination with metabolic causes.
- Conditions
- Cerebral Hypoxia, Severe Traumatic Brain Injury
- Being tested
- Near infrared spectroscopy neuromonitor to prevent cerebral desaturation
- Keywords
- Severe Traumatic Brain Injury, Cerebral Desaturation, Regional Cerebral Oxygen Saturation, Neurosurgical Intensive Care Unit
- Medical subject headings
- Hypoxia, Brain, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopy neuromonitor to prevent cerebral desaturationDevice
patients were assigned into active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA) [17]. After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors.
| Study group | Role | What they receive |
|---|---|---|
| Near infrared spectroscopy neuromonitor | Experimental | Patients were assigned into active treatment (intervention) with cerebral oximetry monitoring using Near infrared spectroscopy monitoring (NIRS) bilaterally (Root; Prime Medical Corporation, MASIMO, USA). After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors. Once values had stabilized, the screen was electronically blinded, and the time monitoring and baseline parameters were recorded by taking the data frequency of 1 minute, 3 minutes after the start recording. For the intervention group, an alarm threshold at 55% of the resting baseline rSO2 value was established. Continuous rSO2 values were stored on a floppy disk with a 15-second update for the duration of the perioperative period. Receives: Device: Near infrared spectroscopy neuromonitor to prevent cerebral desaturation |
| No neuromonitor | No intervention | For usual care patients, the best clinical practices aim at maintaining hemoglobin (Hb) levels greater than 7 g/dl, blood glucose within the institutional normal range of 80-180 mg/dl, and mean arterial pressure (MAP) of 65 mmHg in the ICU and were monitored for invasive arterial blood pressure, peripheral O2 saturation (SpO2), and electrocardiograms. Sedative and paralysis agents were given; keep the Richmond Agitation Sedation Scale (RASS) less than -3 and the Bispectral Index (BIS) 40-60 monitoring based on bedside intensivist judgment, including fentanyl, propofol, midazolam, and cisatracurium. Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 ml/kg, a respiratory rate adjusted to maintain normocapnia, an inspired oxygen fraction adjusted to maintain SpO2 above 95%, and an inspiratory/expiratory ratio of 1:2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale (mRS) followed up at 1 year
Documentation in the medical record of a Modified Rankin Score (mRS). The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Apr 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral HypoxiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a prospective study, 80 patients were randomized to either application of near-infrared reflectance spectroscopy (NIRS) monitoring with active display or attempt to make an intervention to keep regional cortical cerebral oxygen saturation (rSO2) ≥ 55% by increased cardiac output, mean arterial pressure, and adjusting the ventilator to hypoventilation (PaCO2 40-45 mmHg) (exclude in radiographic brain herniation) (intervention, n = 40), compared with usual care (n = 40). Clinical outcomes were assessed by a blind observer. Data collection comprised of patients' demographic data, intervention process, and outcomes of treatment assessed by modified Rankin scale (mRS) followed up at 1 year.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PANU BOONTOTERM, MD., FRCNST, Principal investigator, Phramongkutklao College of Medicine and HospitalSuthee Panichkul, MD., Study director, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306950
- Sponsor's protocol ID
- PMK-00098
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets used and/or analysed during the current study are available from the corresponding author on reasonable request. The data are not publicly available due to information that could compromise the privacy of research participants.
Publications
Roldan M, Kyriacou PA. Near-Infrared Spectroscopy (NIRS) in Traumatic Brain Injury (TBI). Sensors (Basel). 2021 Feb 24;21(5):1586. doi: 10.3390/s21051586.
PubMed 33668311Davies DJ, Su Z, Clancy MT, Lucas SJ, Dehghani H, Logan A, Belli A. Near-Infrared Spectroscopy in the Monitoring of Adult Traumatic Brain Injury: A Review. J Neurotrauma. 2015 Jul 1;32(13):933-41. doi: 10.1089/neu.2014.3748. Epub 2015 Apr 17.
PubMed 25603012Sen AN, Gopinath SP, Robertson CS. Clinical application of near-infrared spectroscopy in patients with traumatic brain injury: a review of the progress of the field. Neurophotonics. 2016 Jul;3(3):031409. doi: 10.1117/1.NPh.3.3.031409. Epub 2016 Apr 25.
PubMed 27226973Viderman D, Ayapbergenov A, Abilman N, Abdildin YG. Near-infrared spectroscopy for intracranial hemorrhage detection in traumatic brain injury patients: A systematic review. Am J Emerg Med. 2021 Dec;50:758-764. doi: 10.1016/j.ajem.2021.09.070. Epub 2021 Oct 3.
PubMed 34879500Mathieu F, Khellaf A, Ku JC, Donnelly J, Thelin EP, Zeiler FA. Continuous Near-infrared Spectroscopy Monitoring in Adult Traumatic Brain Injury: A Systematic Review. J Neurosurg Anesthesiol. 2020 Oct;32(4):288-299. doi: 10.1097/ANA.0000000000000620.
PubMed 31306264Fawaz R, Laitselart P, Morvan JB, Riff JC, Delmas JM, Dagain A, Joubert C. Application of near-infrared spectroscopy to triage of traumatic brain injuries in high-intensity conflicts. BMJ Mil Health. 2024 May 22;170(3):273-274. doi: 10.1136/military-2022-002301. No abstract available.
PubMed 36600643Brogan RJ, Kontojannis V, Garara B, Marcus HJ, Wilson MH. Near-infrared spectroscopy (NIRS) to detect traumatic intracranial haematoma: A systematic review and meta-analysis. Brain Inj. 2017;31(5):581-588. doi: 10.1080/02699052.2017.1287956. Epub 2017 Apr 25.
PubMed 28440675Boontoterm P, Sakoolnamarka S, Urasyanandana K, Fuengfoo P. Clinical impact of cerebral near-infrared reflectance spectroscopy on the management of severe traumatic brain injury. Chin J Traumatol. 2026 May 29:S1008-1275(26)00109-4. doi: 10.1016/j.cjtee.2025.05.011. Online ahead of print.
PubMed 42431819
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Cerebral Oximetry And Avoid Cerebral Deoxygenation In Severe Traumatic Brain Injury.
- ClinicalTrials.gov ID
- NCT06306950
- Acronym / sponsor ID
- PMK-00098
- Conditions
- Cerebral Hypoxia, Severe Traumatic Brain Injury
- Keywords
- Severe Traumatic Brain Injury, Cerebral Desaturation, Regional Cerebral Oxygen Saturation, Neurosurgical Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 Mar 2024 (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.
Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients.
Detailed description
We conducted a prospective interventional study. Data from all 80 severe traumatic brain injury patients were randomized to either perioperative cerebral regional oxygen saturation (rSO2) monitoring with an intervention protocol to prevent cerebral desaturation (intervention, n = 40), or underwent blinded rSO2 monitoring (control, n = 40). Predefined clinical outcomes were assessed by a blinded observer. 40 were retrieved on April 1, 2021 to February 28, 2024. Data collection comprised of patients' demographic data, treatment process, and outcomes of treatment was implemented in the intensive care unit. The pre-intervention included all consecutive severe traumatic brain injury patients admitted as participants. After ethic approval in all methods and obtaining written informed consent from the legal relatives, severe traumatic brain injury patients were enrolled on the basis of inclusion criteria of age ≥ 20 years, Patients were recruited from the preoperative clinic in cases of neurosurgery with agreement. Upon arrival in the emergency department, the randomization envelope was opened, and patients were assigned into either active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA). After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors. Once values had stabilized, the screen was electronically blinded, and the time monitoring and baseline parameters were recorded by taking the data frequency of 1 minute, 3 minutes after the start recording. For the intervention group, an alarm threshold at 55% of the resting baseline rSO2 value was established. Continuous rSO2 values were stored on a floppy disk with a 15-second update for the duration of the perioperative period. With the application of the scalp dressing and before leaving the ICU, monitoring was discontinued, and optodes were removed after discharge from the ICU for 10 days.
For all severe traumatic brain injury patients, the best clinical practices aim at maintaining hemoglobin (Hb) levels greater than 7 g/dl, blood glucose within the institutional normal range of 80-180 mg/dl, and mean arterial pressure (MAP) of 65 mmHg in the intensive care unit. In the intervention group, a prioritized management protocol was used to maintain rSO2 values at or above 55% of the baseline threshold. With a decrease in rSO2, the patient's head position was checked to ensure that it had not been rotated or kinked, and the face was observed to detect plethora. If PaCO2 or end-tidal CO2 was below 40 mmHg during positive pressure ventilation, ventilation was reduced to achieve PaCO2 ≥ 40 mmHg. If MAP was < 65 mmHg, 40 μg increments of intravenous norepinephrine were administered to achieve an MAP ≥ 65 mmHg. If the cardiac index was < 2.0 L/m2/min, administration of dobutamine increased to 2.5 L/m2/min. In patients with persistent rSO2 below the treatment threshold, FiO2 was increased. If Hb was below 7 g/dl, a red blood cell transfusion was administered immediately. Cerebral oximetry monitoring was continued after discharge from the intensive care unit for 10 days. To maintain participant blindness, no study group identifiers were included with the patient or in the patients' charts. For neurosurgical intensive care unit postoperatively, all patients were transferred to an autonomous, protocol-given, "closed" neuro-intensive care unit under the exclusion care of an intensive care unit intensivist without direct reference to the attending neurosurgeons or anesthesiologists. Criteria for discharge from the intensive care unit comprised (1) hemodynamic stability defined as absence of vasopressor or inotropic drugs, removal of arterial and pulmonary artery or central venous catheters, and absence of cardiac arrhythmias; (2) post-extubation respiratory parameter adequacy with maintenance of pulse oximetry (SpO2) > 95% with supplemental O2 below 5 L/min; (3) level of consciousness appropriate sufficient to protect their airway; and (4) good kidney function (urinary output ≥ 0.5 mL/kg/hr). Data on ICU admission and discharge times, and use of a vasopressor were obtained from the intensive care unit database.
The sample size was based upon a projected near infrared spectroscopy (NIRS)-derived tissue oxygenation published in Annual Intensive Care 2012 about the correlation between near infrared spectroscopy (NIRS) in anesthesia and intensive care and brain tissue oxygenation and major organ function. As a priority assumption, we hypothesized that a 50% reduction in the incidence of overall complications would be associated with active NIRS cerebral oximetry. Accepting a p-value < 0.05 for statistical significance and a β error of 0.2, we determined that 40 patients in each group were required for this study. The randomization method was done by blinded envelopes assigning treatment allocation and placing them in computer-generated random order, which were written in order to sequentially identify each subject that registered in this protocol and was disclosed in the neurosurgical ICU. Cerebral deoxygenation means a reduction in saturation below 55% of baseline for 1 minute or longer. To minimize the probability of patients reaching these levels, interventions to improve cerebral oxygenation were administered when rSO2 decreased to < 55% of baseline for > 15 s. Mean and minimum values of rSO2. Categorical values are presented as numbers (percentage) and were analyzed using contingency table analysis, Fisher's exact test, χ2, and Wilcoxon's rank sum tests as appropriate. Continuous variables are presented as mean ± SD using an unpaired t-test or ANOVA for analysis, with a p-value < 0.05 required for statistical significance.
80 patients in the ICU were monitored for invasive arterial blood pressure, peripheral O2 saturation (SpO2), and electrocardiograms. Sedative and paralysis agents were given; keep the Richmond Agitation Sedation Scale (RASS) less than -3 and the Bispectral Index (BIS) 40-60 monitoring based on bedside intensivist judgment, including fentanyl, propofol, midazolam, and cisatracurium. Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 ml/kg, a respiratory rate adjusted to maintain normocapnia, an inspired oxygen fraction adjusted to maintain SpO2 above 95%, and an inspiratory/expiratory ratio of 1:2. The inclusion criteria were age more than 20 years old, Severe traumatic brain injury defined as Glasgow coma scale < 8, and the exclusion criteria were patients who had a pregnancy, an infection at the forehead, a status epilepticus, a history of drug addiction, and Severe traumatic brain injury combination with metabolic causes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In a prospective study, 80 patients were randomized to either application of near-infrared reflectance spectroscopy (NIRS) monitoring with active display or attempt to make an intervention to keep regional cortical cerebral oxygen saturation (rSO2) ≥ 55% by increased cardiac output, mean arterial pressure, and adjusting the ventilator to hypoventilation (PaCO2 40-45 mmHg) (exclude in radiographic brain herniation) (intervention, n = 40), compared with usual care (n = 40). Clinical outcomes were assessed by a blind observer. Data collection comprised of patients' demographic data, intervention process, and outcomes of treatment assessed by modified Rankin scale (mRS) followed up at 1 year.
| Arm | Type | Receives |
|---|---|---|
| Near infrared spectroscopy neuromonitor | Experimental | Device: Near infrared spectroscopy neuromonitor to prevent cerebral desaturationPatients were assigned into active treatment (intervention) with cerebral oximetry monitoring using Near infrared spectroscopy monitoring (NIRS) bilaterally (Root; Prime Medical Corporation, MASIMO, USA). After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors. Once values had stabilized, the screen was electronically blinded, and the time monitoring and baseline parameters were recorded by taking the data frequency of 1 minute, 3 minutes after the start recording. For the intervention group, an alarm threshold at 55% of the resting baseline rSO2 value was established. Continuous rSO2 values were stored on a floppy disk with a 15-second update for the duration of the perioperative period. |
| No neuromonitor | No intervention | –For usual care patients, the best clinical practices aim at maintaining hemoglobin (Hb) levels greater than 7 g/dl, blood glucose within the institutional normal range of 80-180 mg/dl, and mean arterial pressure (MAP) of 65 mmHg in the ICU and were monitored for invasive arterial blood pressure, peripheral O2 saturation (SpO2), and electrocardiograms. Sedative and paralysis agents were given; keep the Richmond Agitation Sedation Scale (RASS) less than -3 and the Bispectral Index (BIS) 40-60 monitoring based on bedside intensivist judgment, including fentanyl, propofol, midazolam, and cisatracurium. Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 ml/kg, a respiratory rate adjusted to maintain normocapnia, an inspired oxygen fraction adjusted to maintain SpO2 above 95%, and an inspiratory/expiratory ratio of 1:2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- age more than 20 years old
- severe traumatic brain injury defined as Glasgow coma scale < 8
Key exclusion criteria (5 listed)
- pregnancy
- infection at the forehead
- status epilepticus
- history of drug addiction
- severe traumatic brain injury combination with metabolic causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near infrared spectroscopy neuromonitor to prevent cerebral desaturationpatients were assigned into active treatment (intervention) or usual care (control) groups with cerebral oximetry monitoring using NIRS bilaterally (Root; Prime Medical Corporation, MASIMO, USA) [17]. After cleansing the adjacent skin area with alcohol, an adhesive optode pad was placed over each frontal to temporal area. Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors. | Device | Near infrared spectroscopy neuromonitor |
Primary outcome
modified Rankin scale (mRS) followed up at 1 year
Time frame: 1 year
Documentation in the medical record of a Modified Rankin Score (mRS). The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Results publication: PubMed 33668311Roldan M, Kyriacou PA. Near-Infrared Spectroscopy (NIRS) in Traumatic Brain Injury (TBI). Sensors (Basel). 2021 Feb 24;21(5):1586. doi: 10.3390/s21051586.
- Results publication: PubMed 25603012Davies DJ, Su Z, Clancy MT, Lucas SJ, Dehghani H, Logan A, Belli A. Near-Infrared Spectroscopy in the Monitoring of Adult Traumatic Brain Injury: A Review. J Neurotrauma. 2015 Jul 1;32(13):933-41. doi: 10.1089/neu.2014.3748. Epub 2015 Apr 17.
- Results publication: PubMed 27226973Sen AN, Gopinath SP, Robertson CS. Clinical application of near-infrared spectroscopy in patients with traumatic brain injury: a review of the progress of the field. Neurophotonics. 2016 Jul;3(3):031409. doi: 10.1117/1.NPh.3.3.031409. Epub 2016 Apr 25.
- Results publication: PubMed 34879500Viderman D, Ayapbergenov A, Abilman N, Abdildin YG. Near-infrared spectroscopy for intracranial hemorrhage detection in traumatic brain injury patients: A systematic review. Am J Emerg Med. 2021 Dec;50:758-764. doi: 10.1016/j.ajem.2021.09.070. Epub 2021 Oct 3.
- Results publication: PubMed 31306264Mathieu F, Khellaf A, Ku JC, Donnelly J, Thelin EP, Zeiler FA. Continuous Near-infrared Spectroscopy Monitoring in Adult Traumatic Brain Injury: A Systematic Review. J Neurosurg Anesthesiol. 2020 Oct;32(4):288-299. doi: 10.1097/ANA.0000000000000620.
- Results publication: PubMed 36600643Fawaz R, Laitselart P, Morvan JB, Riff JC, Delmas JM, Dagain A, Joubert C. Application of near-infrared spectroscopy to triage of traumatic brain injuries in high-intensity conflicts. BMJ Mil Health. 2024 May 22;170(3):273-274. doi: 10.1136/military-2022-002301. No abstract available.
- Results publication: PubMed 28440675Brogan RJ, Kontojannis V, Garara B, Marcus HJ, Wilson MH. Near-infrared spectroscopy (NIRS) to detect traumatic intracranial haematoma: A systematic review and meta-analysis. Brain Inj. 2017;31(5):581-588. doi: 10.1080/02699052.2017.1287956. Epub 2017 Apr 25.
- Derived from this study: PubMed 42431819Boontoterm P, Sakoolnamarka S, Urasyanandana K, Fuengfoo P. Clinical impact of cerebral near-infrared reflectance spectroscopy on the management of severe traumatic brain injury. Chin J Traumatol. 2026 May 29:S1008-1275(26)00109-4. doi: 10.1016/j.cjtee.2025.05.011. Online ahead of print.
- Individual participant dataSharing planned: No. The data sets used and/or analysed during the current study are available from the corresponding author on reasonable request. The data are not publicly available due to information that could compromise the privacy of research participants.
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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. This study is not recruiting at the moment.
PANU BOONTOTERM, MD., FRCNST principal investigator
Phramongkutklao College of Medicine and Hospital
Suthee Panichkul, MD. study director
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared spectroscopy neuromonitor to prevent cerebral desaturation in people with Cerebral Hypoxia and Severe Traumatic Brain Injury, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (mRS) followed up at 1 year (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 NCT06306950, which also lists 8 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 15 Mar 2024.