Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia

NCT03024021 | Completed

• 1 other identifier: 29/3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoxic-Ischemic Encephalopathy; Post-Cardiorespiratory Arrest Coma; Cardiac Arrest

Keywords

therapeutic hypothermia; targeted temperature management; neurological outcome; post-cardiac arrest syndrome

Outcome Measures

Primary Outcomes (1)

• Measure of cerebral oximetry

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

  8 times during the first 48 hours of hospitalization

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

  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

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

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing therapeutic hypothermia after cardiac arrest in a tertiary intensive care unit

You may qualify if:

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

You may not qualify if:

• Patients under 18 years
• Patients unsuitable for therapeutic hypothermia

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Study Sites (1)

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

Location

Related Publications (3)

• Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.

  PMID: 24795284 BACKGROUND

• Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.

  PMID: 27733184 RESULT

• Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.

  PMID: 26291387 RESULT

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Heart Arrest; Post-Cardiac Arrest Syndrome

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Brain Injuries; Reperfusion Injury; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Aykut Saritas

  Tepecik Research and Training Hospital

  STUDY DIRECTOR

• Burcu Acar Cinleti

  suat seren research and training hospital

  STUDY CHAIR

• Ciler Zincircioglu

  Tepecik Research and Training Hospital

  STUDY CHAIR

• İsil Kose

  Tepecik Research and Training Hospital

  STUDY CHAIR

• Ugur Uzun

  Tepecik Research and Training Hospital

  STUDY CHAIR

• Nimet Senoglu

  Tepecik Research and Training Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 18, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

TU (1)