Cardiopulmonary ResuscitationNCT03238287
Manual and Mechanical Chest Compression During In-hospital Witnessed Cardiac Arrests Using Cerebral Oximetry
A study testing Mechanical chest compression and Manuel chest compression in people with Cardiopulmonary Resuscitation, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Mechanical chest compression and Manuel chest compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Medical School
Eskişehir, 26000
About this study
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
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.
Read the 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.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Mechanical chest compression, Manuel chest compression
- Keywords
- Emergency, Mechanical chest compression, Cerebral oximetry
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical chest compressionDevice
Also called LUCAS2
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.
Manuel chest compressionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Mechanical chest compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral tissue oxygen saturation level
Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation
Measured: 20-45 second
Secondary outcomes (3)
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)
Measured: 6th hour and 24th hours
Hospital discharge
Hospital discharge with good neurological outcome (cerebral performance category scale 1-2)
Measured: 1- 30 days
Additional pathology
Evaluation of additional pathology (e.g., renal failure and cardiac failure) after resuscitation during in-hospital observation.
Measured: 1- 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start16 Oct 2017
- Primary completion4 Jan 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Projects Commission of ESOGU
- Responsible party
- Principal investigator, Filiz Baloglu Kaya, Eskisehir Osmangazi University
- Investigators
- Filiz Baloğlu Kaya, Study chair, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238287
- Sponsor's protocol ID
- 3939444
- Other IDs
- 2016-1385
- Status last verified
- Jan 2020
- First submitted
- 25 Jul 2017
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participants data for all primary and secondary outcome measures will be made available.
Publications
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.
PubMed 33071075
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03238287
- Acronym / sponsor ID
- 3939444
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Emergency, Mechanical chest compression, Cerebral oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- Scientific Research Projects Commission of ESOGU
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manuel chest compression | Active comparator | Other: Manuel chest compressionIn 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. |
| Mechanical chest compression | Active comparator | Device: Mechanical chest compressionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- Younger than 18 years old.
- Out-of-hospital cardiac arrest.
- Exposure to trauma.
- Pregnancy.
- Length of sternum not between 170- 303 mm (devise requirements).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical chest compressionAlso: LUCAS2In 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 |
| Manuel chest compressionIn 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 |
Primary outcome
Regional cerebral tissue oxygen saturation level
Time frame: 20-45 second
Comparison of regional cerebral tissue oxygen saturation levels between two groups during cardiopulmonary resuscitation
3 secondary outcomes
Survival at the 6th hour and 24th hour after resuscitation,
Time frame: 6th hour and 24th hours
Hospital discharge
Time frame: 1- 30 days
Additional pathology
Time frame: 1- 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 33071075Baloglu 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.
- Individual participant dataSharing planned: Yes. De-identified individual participants data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Baloğlu Kaya study chair
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical chest compression and Manuel chest compression in people with Cardiopulmonary Resuscitation, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional cerebral tissue oxygen saturation level (time frame: 20-45 second). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.