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

Phase 2

Active, not recruiting

• Conditions: Cardiac Arrest; Cardiopulmonary Arrest With Successful Resuscitation; Cerebral Oxygenation
• Interventions: Combination Product: Cerebral oximetry (near infrared) based CPR-Algorithm

• Registration Number: NCT03911908
• Lead Sponsor: Dr. Serge Thal

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Study Start: 2019-07-01
• Primary Completion: 2022-05-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31
• Study Completion: 2023-05-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERC guided CPR (intervention/NIRS group)	Cerebral oximetry (near infrared) based CPR-Algorithm	CPR protocol according to current ERC guidelines (2015)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time-to-ROSC	DAY 1	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)	DAY 30, DAY 180, DAY 360	Neurofunctional recovery, total score, range: 1-5
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
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

Trial Locations

Locations (1)

Medical Center of the Johannes Gutenberg-University Mainz; 🇩🇪 Mainz, Rheinland-Pfalz, Germany