Impact of NIRS-guided Cardiopulmonary Resuscitation After Cardiac Arrest on Resuscitation Rate

NCT03911908 | Unknown Phase 2 FDA Device

• 2 other identifiers: 2018-13666U1111-1231-2797
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden cardiac death is one of the main causes of morbidity and mortality worldwide. Cardiac arrest requires prompt intervention by cardiopulmonary resuscitation (CPR). The resuscitation guidelines are the current recommendations for CPR and are revised by expert panels such as the "European Resuscitation Council (ERC)". Up to now, a parameter for assessing the quality of CPR is missing and further monitoring methods are urgently needed. Near-infrared spectroscopy (NIRS) is a portable method for measuring regional oxygen levels in the brain. Recent clinical trials suggest that cerebral oxygenation measured by NIRS may correlate with survival and outcome after cardiac arrest. The investigators propose that NIRS technology may not only be suitable to determine or predict the outcome of the patients, but could also be a useful tool to guide the CPR providers to optimize the CPR techniques and guide the individual treatments/interventions. The present study was therefore designed to determine if NIRS guided CPR with the aim to optimize NIRS values is superior compared to the current standard practice according to published CPR guidelines (return of spontaneous circulation \[ROSC\] rate, short and long-term cerebral performance).

Conditions

Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Cerebral Oxygenation

Keywords

near-infrared spectroscopy; cardiopulmonary resuscitation; cardiac arrest; cerebral oximetry

Outcome Measures

Primary Outcomes (1)

• successful cardiopulmonary resuscitation (CPR)

  Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) \[ROSC: yes/no\]

  DAY 1

Secondary Outcomes (4)

• Time-to-ROSC

  DAY 1

• Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)

  DAY 30, DAY 180, DAY 360

• Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)

  DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)

• The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)

  Discharge from intensive care unit (variable time point, depending on condition of patient)

Other Outcomes (5)

• Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC)

  DAY 1, DAY 2, DAY 3, DAY 4

• S100B blood level after successful return of spontaneous circulation (ROSC)

  DAY 1, DAY 2, DAY 3, DAY 4

• plasminogen activator inhibitor 1/2 (PAI1/2) blood level after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC) after successful return of spontaneous circulation (ROSC)

  DAY 1, DAY 2, DAY 3, DAY 4

Study Arms (2)

ERC guided CPR (intervention/NIRS group)

ACTIVE COMPARATOR

CPR protocol according to current ERC guidelines (2015)

Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm

ERC-based CPR (control group)

NO INTERVENTION

modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality

Interventions

Cerebral oximetry (near infrared) based CPR-Algorithm COMBINATION_PRODUCT

If NIRS values do not increase over time until ROSC (target: \>40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.

ERC guided CPR (intervention/NIRS group)

Eligibility Criteria

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

You may qualify if:

• Patients with a cardiac arrest from the age of 18 years (in and out-of-hospital cardiac arrest)

You may not qualify if:

• post-traumatic cardiac arrest
• non-fitting NIRS sensor (size)

Sponsors & Collaborators

• Dr. Serge Thal: lead

Study Sites (1)

Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Serge C Thal, MD

  Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: On group will have NIRS reading available to adjust CPR interventions, whereas the control group will not be able use NIRS readings (masked by cover)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Does near-infrared spectroscopy (NIRS) technology based advanced cardiac life support improve cardiopulmonary resuscitation (CPR) quality in patients (in-house \[IHCA\] and out-of-hospital cardiac arrest \[OHCA\], randomized enrollment immediately with CPR) and thereby improve return of spontaneous circulation (ROSC) rate (primary outcome) and patient outcome compared to European Resuscitation Council (ERC)-based CPR (concealed NIRS recording).

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 11, 2019
• Study Start: July 1, 2019
• Primary Completion: May 22, 2022
• Study Completion: May 5, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)