Out-of-Hospital Cardiac ArrestNCT02056509
The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation.
An observational study of Out-of-Hospital Cardiac Arrest and Sudden Cardiac Death, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted according to 2010 Advanced Cardiac Life… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Sudden Cardiac Death
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Jul 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac arrest patient received CPR in Emergency Department Age > 20 years old
Who may be able to join
- age > 20 years old, < 100 years old
Who cannot join
- Trauma related out of hospital cardiac arrest
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10002
Hui-Chih Wang, +886-2-23123456 ext. 65659, ticoer@ntuh.gov.tw
About this study
Official title: The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation
Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This recommendation emphasizes on the timing and frequency of ventilation during CPR. However, poor clinical evidence had been established concerning adequate volume, airway flow and pressure in each cycle.
There are increasing evidence that hyperventilation during resuscitation reduces pulmonary venous return and, therefore, compromises cardiac output and circulation. Another research reported that using high flow oxygen mask alone during basic life support (BLS) results in better survival rate and overall outcome compared with conventional positive pressure ventilation.
Read more
Our study applies flowmeter to measure ventilation parameters as frequency, duration, exhaled volume and airway pressure on intubated patients who received artificial ventilation during CPR. The parameters will correlate with information from accelerometry and capnometry simultaneously during resuscitation. . Investigators also focus on the influence of chest compression, which increases intra-thoracic pressure considerably. This effect may act against positive pressure ventilation and probably minimize the efficiency in each ventilation or circulation..
Details about how to ventilate one patient during CPR include right timing, duration, adequate volume and coordination are in debate. Unfortunately, current practice based on clinical guidelines emphasizes little on this issue. Investigators are committed to refine contemporary practices and hopefully improve qualities of resuscitation.
Investigators proposed the hypothesis that coordinate chest compression and ventilation may minimize the increasement of airway pressure and improve the effect of circulation
- Keywords
- cardiopulmonary resuscitation,Ventilation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Out of hospital cardiac arrest | Out of hospital cardiac arrest of non-traumatic cause | |
| Unexpected in-hospital cardiac arrest | Unexpected cardiac arrest during emergency department stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of 2- hour recover of spontaneous circulation
Recover of spontaneous circulation lasting for 2 hours describe as successful recover of spontaneous circulation, otherwise failure.
Measured: 2 hours
Secondary outcomes (6)
End tidal carbon-dioxide level
End tidal carbon-dioxide level correlates with successful recovery of spontaneous circulation event
Measured: Measured during and end of resuscitation
Arterial blood gas data
Oxygen and carbon-dioxide tension changes in different ventilation strategy in cardiopulmonary resuscitation
Measured: measured during and end of resuscitaiton
30-day survival rate
Measured: 30 days
90-day neurologic outcome
Measured: 90 days
Survive to discharge
Duration of hospital stay, usually will be recorded in 90 days, occasionally will more than 90 days
Measured: 90 days
Timing of first shockable rhythm
Measured: measured during resuscitaion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Chih Wang, Principal investigator, Emergency department, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056509
- Sponsor's protocol ID
- 201305100RINB
- Status last verified
- Apr 2015
- First submitted
- 21 Jan 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02056509
- Acronym / sponsor ID
- 201305100RINB
- Keywords
- cardiopulmonary resuscitation,Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 6 Feb 2014 (estimated)
- 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.
Airway management and maintaining adequate ventilation during cardiopulmonary resuscitation (CPR) are important. The rule of 30:2 compression-to-ventilation ratios before endotracheal intubation and keeping 1 breath every 6-8 seconds with advanced airway are generally accepted according to 2010 Advanced Cardiac Life Support (ACLS) guideline. This recommendation emphasizes on the timing and frequency of ventilation during CPR. However, poor clinical evidence had been established concerning adequate volume, airway flow and pressure in each cycle.
There are increasing evidence that hyperventilation during resuscitation reduces pulmonary venous return and, therefore, compromises cardiac output and circulation. Another research reported that using high flow oxygen mask alone during basic life support (BLS) results in better survival rate and overall outcome compared with conventional positive pressure ventilation.
Our study applies flowmeter to measure ventilation parameters as frequency, duration, exhaled volume and airway pressure on intubated patients who received artificial ventilation during CPR. The parameters will correlate with information from accelerometry and capnometry simultaneously during resuscitation. . Investigators also focus on the influence of chest compression, which increases intra-thoracic pressure considerably. This effect may act against positive pressure ventilation and probably minimize the efficiency in each ventilation or circulation..
Details about how to ventilate one patient during CPR include right timing, duration, adequate volume and coordination are in debate. Unfortunately, current practice based on clinical guidelines emphasizes little on this issue. Investigators are committed to refine contemporary practices and hopefully improve qualities of resuscitation.
Investigators proposed the hypothesis that coordinate chest compression and ventilation may minimize the increasement of airway pressure and improve the effect of circulation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out of hospital cardiac arrest | – | –Out of hospital cardiac arrest of non-traumatic cause |
| Unexpected in-hospital cardiac arrest | – | –Unexpected cardiac arrest during emergency department stay |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac arrest patient received CPR in Emergency Department Age > 20 years old
Key inclusion criteria (1 listed)
- age > 20 years old, < 100 years old
Key exclusion criteria (1 listed)
- Trauma related out of hospital cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of 2- hour recover of spontaneous circulation
Time frame: 2 hours
Recover of spontaneous circulation lasting for 2 hours describe as successful recover of spontaneous circulation, otherwise failure.
6 secondary outcomes
End tidal carbon-dioxide level
Time frame: Measured during and end of resuscitation
Arterial blood gas data
Time frame: measured during and end of resuscitaiton
30-day survival rate
Time frame: 30 days
90-day neurologic outcome
Time frame: 90 days
Survive to discharge
Time frame: 90 days
Timing of first shockable rhythm
Time frame: measured during resuscitaion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Hui-Chih Wang principal investigator
Emergency department, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-of-Hospital Cardiac Arrest and Sudden Cardiac Death, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Apr 2015. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Chih Wang (+886-2-23123456 ext. 65659, ticoer@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of 2- hour recover of spontaneous circulation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2015.