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

• Sponsor: Dr. Serge Thal (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03911908
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 10

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Cerebral Oxygenation	Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: 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)
• Primary Purpose: Treatment
• Official Title: Impact of a NIRS-guided Cardiopulmonary Resuscitation Algorithm Compared to the Current ERC-guideline Algorithm on ROSC Rate and Patient Outcome After In-hospital and Out-of-hospital Cardiac Arrest
• Actual Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ERC guided CPR (intervention/NIRS group) CPR protocol according to current ERC guidelines (2015)	Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm; If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
No Intervention: ERC-based CPR (control group) modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality

Outcome Measures

Primary Outcome Measures

1. successful cardiopulmonary resuscitation (CPR) [DAY 1]

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

Secondary Outcome Measures

1. Time-to-ROSC [DAY 1]

   Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]

2. Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC) [DAY 30, DAY 180, DAY 360]

   Neurofunctional recovery, total score, range: 1-5

3. 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)]

   Neurofunctional recovery, total score, range: 1-8

4. The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC) [Discharge from intensive care unit (variable time point, depending on condition of patient)]

   Neurofunctional recovery, total score, range: 0-100

Other Outcome Measures

1. Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC) [DAY 1, DAY 2, DAY 3, DAY 4]

   NSE as marker for brain damage after cardiac arrest

2. S100B blood level after successful return of spontaneous circulation (ROSC) [DAY 1, DAY 2, DAY 3, DAY 4]

   S100B as marker for brain damage after cardiac arrest

3. 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]

   PAI1/2 as marker for brain damage after cardiac arrest

4. proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC) [DAY 1, DAY 2, DAY 3, DAY 4]

   proBNDF/BDNF as marker for brain damage after cardiac arrest

5. Neurofilament blood level after successful return of spontaneous circulation (ROSC) [DAY 1, DAY 2, DAY 3, DAY 4]

   Neurofilament as marker for brain damage after cardiac arrest

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• post-traumatic cardiac arrest

• non-fitting NIRS sensor (size)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center of the Johannes Gutenberg-University Mainz	Mainz	Rheinland-Pfalz	Germany	55131

Sponsors and Collaborators

• Dr. Serge Thal

Investigators

• Principal Investigator: Serge C Thal, MD, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Serge Thal, Principal Investigator, Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT03911908
• Other Study ID Numbers: 2018-13666; U1111-1231-2797
• First Posted: Apr 11, 2019
• Last Update Posted: Apr 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Dr. Serge Thal, Principal Investigator, Johannes Gutenberg University Mainz: near-infrared spectroscopy; cardiopulmonary resuscitation; cardiac arrest; cerebral oximetry
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Apr 5, 2022