Manual and Mechanical Chest Compression During In-hospital Witnessed Cardiac Arrests Using Cerebral Oximetry

NCT03238287 | Completed

• 2 other identifiers: 39394442016-1385
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Post-resuscitation neurological impairment is associated with morbidity and especially with late mortality. Thus, because good neurological outcome is vital for a successful resuscitation, it is essential to have sufficient cerebral tissue perfusion and oxygenation during its application. Near-Infrared Spectroscopy (NIRS) is used to evaluate such conditions. NIRS is a non-invasive technique which provides real-time, continuous information about regional cerebral tissue oxygen saturation levels (regional SO2/rSO2). Research on NIRS has been done in many studies including cardiovascular surgery, neurosurgery and their intensive care processes and its effectiveness has been approved. However, there is limited data on its use in cardiac arrests. As stated in the current guidelines, sufficient speed and depth of chest compressions, few interruptions of compressions are key to a successful outcome of resuscitation. The studies with the mechanical chest compression devices showed that the earlier it was applied in out-of-hospital cases, the higher the rates of survival until hospitalization. There is not sufficient number of studies on the routine use of mechanical chest compression devices for in-hospital cases. In case the application of manual resuscitation is not convenient (during patient relocation, procedure at the angiography laboratory, and rush hours of emergency services when staff might fall short), alternative methods will be required. The aim of our study is to compare rSO2 levels measured during resuscitation with manual and mechanical devices in in-hospital (at the emergency department) witnessed cardiac arrest cases and to analyze the impact of both application method and perfusion levels on survival and neurological outcome.

Conditions

Cardiopulmonary Resuscitation

Keywords

Emergency; Mechanical chest compression; Cerebral oximetry

Outcome Measures

Primary Outcomes (1)

• Regional cerebral tissue oxygen saturation level

  Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation

  20-45 second

Secondary Outcomes (3)

• Survival at the 6th hour and 24th hour after resuscitation,

  6th hour and 24th hours

• Hospital discharge

  1- 30 days

• Additional pathology

  1- 30 days

Study Arms (2)

Manuel chest compression

ACTIVE COMPARATOR

In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.

Other: Manuel chest compression

Mechanical chest compression

ACTIVE COMPARATOR

In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.

Device: Mechanical chest compression

Interventions

Mechanical chest compression DEVICE

In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.

Also known as: LUCAS2

Mechanical chest compression

Manuel chest compression OTHER

In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines

Manuel chest compression

Eligibility Criteria

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

You may qualify if:

• years or older.
• In hospital (emergency service) witnessed cardiac arrest.
• Cardiac arrest caused reasons other than trauma.
• Length of sternum between 170- 303 mm (devise requirements).
• Patients' chest width not more than 449 mm (devise requirements).
• Informed consent of first-degree relatives of patients.

You may not qualify if:

• Younger than 18 years old.
• Out-of-hospital cardiac arrest.
• Exposure to trauma.
• Pregnancy.
• Length of sternum not between 170- 303 mm (devise requirements).
• Patients' chest width more than 449 mm (devise requirements).
• Intracranial mass, large infarct or bleeding in the frontal part of the head (rSO2 monitoring area) which might effect the evaluation.
• Lack of informed consent of first-degree relatives of patients.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead
• Scientific Research Projects Commission of ESOGU: collaborator

Study Sites (1)

Eskisehir Osmangazi University Medical School

Eskişehir, 26000, Turkey (Türkiye)

Location

Related Publications (1)

• Baloglu Kaya F, Acar N, Ozakin E, Canakci ME, Kuas C, Bilgin M. Comparison of manual and mechanical chest compression techniques using cerebral oximetry in witnessed cardiac arrests at the emergency department: A prospective, randomized clinical study. Am J Emerg Med. 2021 Mar;41:163-169. doi: 10.1016/j.ajem.2020.06.031. Epub 2020 Jun 28.

  PMID: 33071075 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filiz Baloğlu Kaya

  Eskisehir Osmangazi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 3, 2017
• Study Start: October 16, 2017
• Primary Completion: January 4, 2019
• Study Completion: July 1, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available within one year of study completion.
• Access Criteria: Data access requests will be reviewed by the principal investigator of the study. Requestors will be required to sign a Data Access Agreement.

Locations

TU (1)