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

Primary Purpose

Cardiopulmonary Resuscitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mechanical chest compression
Manuel chest compression
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiopulmonary Resuscitation focused on measuring Emergency, Mechanical chest compression, Cerebral oximetry

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years or older.
  2. In hospital (emergency service) witnessed cardiac arrest.
  3. Cardiac arrest caused reasons other than trauma.
  4. Length of sternum between 170- 303 mm (devise requirements).
  5. Patients' chest width not more than 449 mm (devise requirements).
  6. Informed consent of first-degree relatives of patients.

Exclusion Criteria:

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

Sites / Locations

  • Eskisehir Osmangazi University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Manuel chest compression

Mechanical chest compression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival at the 6th hour and 24th hour after resuscitation,
Survival at the 6th hour and 24th hour after resuscitation and evaluation of neurological outcome (cerebral performance category scale 1-2)
Hospital discharge
Hospital discharge with good neurological outcome (cerebral performance category scale 1-2)
Additional pathology
Evaluation of additional pathology (e.g., renal failure and cardiac failure) after resuscitation during in-hospital observation.

Full Information

First Posted
July 25, 2017
Last Updated
January 30, 2020
Sponsor
Eskisehir Osmangazi University
Collaborators
Scientific Research Projects Commission of ESOGU
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1. Study Identification

Unique Protocol Identification Number
NCT03238287
Brief Title
Manual and Mechanical Chest Compression During In-hospital Witnessed Cardiac Arrests Using Cerebral Oximetry
Official Title
Evaluation of Effectiveness of Cardiopulmonary Resuscitation With Manual and Mechanical Chest Compression Systems During In-hospital (at the Emergency Department) Witnessed Cardiac Arrests Using Cerebral Oximetry
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
Collaborators
Scientific Research Projects Commission of ESOGU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will be a single-center, prospective and randomized study. It will be conducted at the Emergency Department of Eskisehir Osmangazi University Education, Application and Research Hospital. Patients will be allocated to treatment groups by blocked randomization (www.randomizer.org). Advanced cardiac life support algorithm will be initiated as outlined in the current resuscitation guidelines and cardiopulmonary resuscitation (CPR) will be continued either manually or mechanically (with the chest compression system), according to the randomization scheme. Due to the nature of the interventions carried out in the study process, blinding of healthcare providers was not possible. Before the initiation of the study, the team members participating in the study will receive theoretical and practical training on CPR, mechanical chest compression system utilization and NIRS. Patients who develop cardiopulmonary arrest during their clinical evaluation in the emergency department will receive CPR, and the chest compression method will be determined by the senior physician according to the randomization scheme. The manual CPR group will receive chest compressions, respiratory support and medical treatment in accordance with the recommendations of current guidelines. If return of spontaneous circulation (ROSC) is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will be terminated in accordance with the recommendations of current guidelines. The patients on the mechanical chest compression group will receive manual chest compressions until the mechanical compression device is installed (about 15-20 seconds). In this time interval, thorax and sternum measurements will be evaluated for suitability for the study, and mechanical compression device will be installed on patients who are deemed suitable. The patients will receive chest compressions, respiratory support and medical treatment in accordance with the recommendations of current guidelines. If ROSC is achieved, post-resuscitation care will be provided. If ROSC is not achieved, CPR will be terminated in accordance with the recommendations of current guidelines. The presence of ROSC or the decision to terminate CPR will be determined according to the vital signs (arterial blood pressure, heart rate, oxygen saturation with pulse oximeter), end tidal carbon dioxide (ETco2) measurement (with the module device used for the measurement of rSO2) and cardiac assessment with bedside ultrasonography (Vivid e, General Electric Healthcare, China). As soon as cardiopulmonary arrest is identified, sensors measuring the value of rSO2 will be placed on the patient's head bifrontally (forehead area) in order to measure the cerebral perfusion. During CPR, rSO2 values will be continuously recorded. The placement of the sensors and the measurements will be carried out by a medical staff who received necessary training prior to the study. In order not to affect the clinical decisions made during CPR, the rSO2 device will be placed in a convenient area which is out of the CPR performers' eyesight. Arterial blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation on pulse oximeter, primary arrest rhythm, any known diseases (if existent) and defibrillation attempts (if existent) will be recorded on the case report form during CPR. In patients with ROSC, 6-hour and 24-hour survival after CPR, discharge from the hospital with favorable neurologic outcome and the presence of additional pathologies (such as heart failure and neurologic sequelae) will be evaluated. Favorable neurologic outcome was defined as a Cerebral Performance Category score of 1-2. In patients with ROSC, post-resuscitation care will be provided as recommended in the current guidelines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Resuscitation
Keywords
Emergency, Mechanical chest compression, Cerebral oximetry

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manuel chest compression
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mechanical chest compression
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mechanical chest compression
Other Intervention Name(s)
LUCAS2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manuel chest compression
Intervention Description
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
Primary Outcome Measure Information:
Title
Regional cerebral tissue oxygen saturation level
Description
Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation
Time Frame
20-45 second
Secondary Outcome Measure Information:
Title
Survival at the 6th hour and 24th hour after resuscitation,
Description
Survival at the 6th hour and 24th hour after resuscitation and evaluation of neurological outcome (cerebral performance category scale 1-2)
Time Frame
6th hour and 24th hours
Title
Hospital discharge
Description
Hospital discharge with good neurological outcome (cerebral performance category scale 1-2)
Time Frame
1- 30 days
Title
Additional pathology
Description
Evaluation of additional pathology (e.g., renal failure and cardiac failure) after resuscitation during in-hospital observation.
Time Frame
1- 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filiz Baloğlu Kaya
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Study Chair
Facility Information:
Facility Name
Eskisehir Osmangazi University Medical School
City
Eskişehir
ZIP/Postal Code
26000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participants data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within one year of study completion.
IPD Sharing 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.
Citations:
PubMed Identifier
33071075
Citation
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.
Results Reference
derived

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

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