search
Back to results

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

Primary Purpose

Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation

Status
Active
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cerebral oximetry (near infrared) based CPR-Algorithm
Sponsored by
Dr. Serge Thal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical Center of the Johannes Gutenberg-University Mainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ERC guided CPR (intervention/NIRS group)

ERC-based CPR (control group)

Arm Description

CPR protocol according to current ERC guidelines (2015)

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

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

Time-to-ROSC
Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 1-5
Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 1-8
The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)
Neurofunctional recovery, total score, range: 0-100

Full Information

First Posted
April 8, 2019
Last Updated
March 30, 2023
Sponsor
Dr. Serge Thal
search

1. Study Identification

Unique Protocol Identification Number
NCT03911908
Brief Title
Impact of NIRS-guided Cardiopulmonary Resuscitation After Cardiac Arrest on Resuscitation Rate
Acronym
NICA
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 22, 2022 (Actual)
Study Completion Date
May 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Serge Thal

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Cardiopulmonary Arrest With Successful Resuscitation, Cerebral Oxygenation
Keywords
near-infrared spectroscopy, cardiopulmonary resuscitation, cardiac arrest, cerebral oximetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderOutcomes 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)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERC guided CPR (intervention/NIRS group)
Arm Type
Active Comparator
Arm Description
CPR protocol according to current ERC guidelines (2015)
Arm Title
ERC-based CPR (control group)
Arm Type
No Intervention
Arm Description
modified CPR protocol based on current ERC guidelines (2015), extended by evaluation of NIRS readings and interventions to optimize CPR quality
Intervention Type
Combination Product
Intervention Name(s)
Cerebral oximetry (near infrared) based CPR-Algorithm
Intervention Description
If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
Primary Outcome Measure Information:
Title
successful cardiopulmonary resuscitation (CPR)
Description
Influence of the intervention on the number of patients with successful return of spontaneous circulation (ROSC) during cardiopulmonary resuscitation (CPR) [ROSC: yes/no]
Time Frame
DAY 1
Secondary Outcome Measure Information:
Title
Time-to-ROSC
Description
Time from start of cardiopulmonary resuscitation (CPR) until successful return of spontaneous circulation (ROSC) [min]
Time Frame
DAY 1
Title
Cerebral Performance Category (CPC) after successful return of spontaneous circulation (ROSC)
Description
Neurofunctional recovery, total score, range: 1-5
Time Frame
DAY 30, DAY 180, DAY 360
Title
Glasgow Outcome Scale Extended (GOS-E) after successful return of spontaneous circulation (ROSC)
Description
Neurofunctional recovery, total score, range: 1-8
Time Frame
DAY 30, DAY 180, DAY 360 after successful return of spontaneous circulation (ROSC)
Title
The Bathel-Index (Barthel) after successful return of spontaneous circulation (ROSC)
Description
Neurofunctional recovery, total score, range: 0-100
Time Frame
Discharge from intensive care unit (variable time point, depending on condition of patient)
Other Pre-specified Outcome Measures:
Title
Neuron Specific Enolase (NSE) blood level after successful return of spontaneous circulation (ROSC)
Description
NSE as marker for brain damage after cardiac arrest
Time Frame
DAY 1, DAY 2, DAY 3, DAY 4
Title
S100B blood level after successful return of spontaneous circulation (ROSC)
Description
S100B as marker for brain damage after cardiac arrest
Time Frame
DAY 1, DAY 2, DAY 3, DAY 4
Title
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)
Description
PAI1/2 as marker for brain damage after cardiac arrest
Time Frame
DAY 1, DAY 2, DAY 3, DAY 4
Title
proBNDF/BDNF blood level after successful return of spontaneous circulation (ROSC)
Description
proBNDF/BDNF as marker for brain damage after cardiac arrest
Time Frame
DAY 1, DAY 2, DAY 3, DAY 4
Title
Neurofilament blood level after successful return of spontaneous circulation (ROSC)
Description
Neurofilament as marker for brain damage after cardiac arrest
Time Frame
DAY 1, DAY 2, DAY 3, DAY 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge C Thal, MD
Organizational Affiliation
Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center of the Johannes Gutenberg-University Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs