Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit.

NCT06306950 | Completed DMC

• 1 other identifier: PMK-00098
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Hypoxia; Severe Traumatic Brain Injury

Keywords

Severe Traumatic Brain Injury; Cerebral Desaturation; Regional Cerebral Oxygen Saturation; Neurosurgical Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

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.

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.

Interventions

Near infrared spectroscopy neuromonitor to prevent cerebral desaturation DEVICE

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.

Near infrared spectroscopy neuromonitor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 20 years old
• severe traumatic brain injury defined as Glasgow coma scale \< 8

You may not qualify if:

• pregnancy
• infection at the forehead
• status epilepticus
• history of drug addiction
• severe traumatic brain injury combination with metabolic causes

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao College of Medicine and Hospital

Bangkok, 10400, Thailand

Location

Related Publications (7)

• 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.

  PMID: 33668311 RESULT

• Davies 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.

  PMID: 25603012 RESULT

• Sen 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.

  PMID: 27226973 RESULT

• Viderman 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.

  PMID: 34879500 RESULT

• Mathieu 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.

  PMID: 31306264 RESULT

• Fawaz 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.

  PMID: 36600643 RESULT

• Brogan 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.

  PMID: 28440675 RESULT

MeSH Terms

Conditions

Hypoxia, Brain; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• PANU BOONTOTERM, MD., FRCNST

  Phramongkutklao College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

• Suthee Panichkul, MD.

  Phramongkutklao College of Medicine and Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)