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Completed

NCT Number: NCT03024021

Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Injuries Brain Ischemia Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Arrest Heart Diseases Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Cardiac Arrest Syndrome Post-Cardiorespiratory Arrest Coma Postoperative Complications Reperfusion Injury Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

About this study

Our study is planned as a prospective observational study. Patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6 hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from ICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at least 18 years old
  • Patients undergoing therapeutic hypothermia

Exclusion criteria

  • Patients under 18 years
  • Patients unsuitable for therapeutic hypothermia

Treatment and study plan

Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)

Device

As we start the targeted temperature management protocol (24 hours of hypothermia adjusted to 33-36 C and afterwards up to five days of normothermia [36.5 C]) NIRS sensor pads will be placed over the right and left frontal area. Regional cerebral oxygen values will be continuously recorded at the NIRS monitor. Tests to assess neurological outcome will be performed. Patients will be assessed in terms of neurological performance tests and regional cerebral oxygen.

Primary outcomes

  1. Measure of cerebral oximetry

    Time frame: 8 times during the first 48 hours of hospitalization

    During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres.

Secondary outcomes

  1. The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score

    Time frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed

    The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the CPC score.

    CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death. CPC will be evaluated at the time of admission to intensive care unit and day 21.CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5).

Other outcomes

  1. The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with Four score

    Time frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed

    The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the Fourscore (Full Outline of UnResponsiveness):It evaluates four functional categories: eye response, motor response, brainstem reflexes, and respiration pattern (including mechanical ventilation). All the four categories are scored from 0 to 4 points, with 4 representing normal, and 0 indicating no function.

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Official study title

The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2017
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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