Ventilation During Cardiopulmonary ResuscitationNCT02420483
Lung Ventilation During Cardiopulmonary Resuscitation
A study testing Cardiopulmonary resuscitation chest compressions in people with Ventilation During Cardiopulmonary Resuscitation, run by University of Thessaly at 1 site in Greece.
Trial summary
The authors to measure passive tidal volumes generated during external chest compressions in order to determine whether chest compressions alone without any mechanical ventilatory support in cardiopulmonary resuscitation can provide adequate ventilation. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ventilation During Cardiopulmonary Resuscitation
- What is being tested?
- Cardiopulmonary resuscitation chest compressions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2015to Dec 2018
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-55 years
- ASA I-II
- candidates for surgical operation who will receive general anesthesia
Who cannot join
- surgical operation in the chest
- musculoskeletal diseases
- cardiopulmonary or vascular acute or chronic diseases
- history of pneumothorax
- thromboembolism
- osteoporosis menopause history of current rib or sternal or clavicle fractures
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Uh Larissa
Larissa, Thessaly, 41110
KONSTANTINOS PRATSAS, MD, +30 2413501351, konvol1@gmail.com
DEMETRA BAGKA, MD, +30241302964, dbagka@gmail.com
About this study
The authors to measure passive tidal volumes generated during external chest compressions in order to determine whether chest compressions alone without any mechanical ventilatory support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II, candidates for surgical operation, who will receive general anesthesia. Patients who will be operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular acute or chronic diseases, who had history of pneumothorax, of thromboembolism, osteoporosis, menopause, history of current rib or sternal or clavicle fractures, will be excluded. All eligible patients will enter the study and will receive general anesthesia and intubation according to treating doctors' decision.
Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A pneumotachograph will be then connected to the ventilatory circuit so that respiratory efforts (volume, airway pressure and flow) can be continuously monitored at real time.
Read more
An esophageal catheter will be then inserted to monitor esophageal pressures and to provide data for lung mechanics calculation. Following the above procedures and before any surgical procedure, chest compressions will be performed to the patient by a senior anesthesiologist according to ERC guidelines of 2010 for 30 seconds.
Following chest compressions, patients will be evaluated for possible complications and after the establishment of stable conditions surgical procedures will follow. After the end of the surgical operation clinical and chest ultrasound evaluation will be performed.
Written inform consent will be obtained by all patients before procedures.
- Being tested
- Cardiopulmonary resuscitation chest compressions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary resuscitation chest compressionsOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Cardiopulmonary resuscitation with measurement of tidal volume, airway pressure and flow by a pneumotachograph and airway, oesophageal pressure sensors Receives: Other: Cardiopulmonary resuscitation chest compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume during cardiopulmonary resuscitation
Tidal volume will be assessed by a pneumotachograph (Hans Rudolf USA)
Measured: 30 seconds
Secondary outcomes (2)
Esophageal pressures during cardiopulmonary resuscitation
esophageal pressures will be assessed with an esophageal balloon-catheter that will be introduced via the nares while the patients is still awake and will be positioned at 40 cm from the nares. Correct positioning will be confirmed by the demonstration of negative pressure swings against an occluded airway.
Measured: 30 seconds
Lung compliance before and at the end of cardiopulmonary resuscitation
Lung compliance will be assessed as the ratio of tidal volume change over transpulmonary pressure changes (subtracting oesophageal pressures from airway pressures) during tidal breathing (average of 10 breaths); oesophageal will be used as a measure of pleural pressures.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation During 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMOSTHENES MAKRIS, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420483
- Sponsor's protocol ID
- 49304 11/11/13
- Status last verified
- May 2017
- First submitted
- 27 Mar 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ventilation During Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT02420483
- Acronym / sponsor ID
- 49304 11/11/13
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Apr 2015 (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.
The authors to measure passive tidal volumes generated during external chest compressions in order to determine whether chest compressions alone without any mechanical ventilatory support in cardiopulmonary resuscitation can provide adequate ventilation. The authors will study 25 volunteers who meet the following inclusion criteria: age 18-55 years, ASA I-II, candidates for surgical operation, who will receive general anesthesia. Patients who will be operated in the chest, who present musculoskeletal diseases, cardiopulmonary or vascular acute or chronic diseases, who had history of pneumothorax, of thromboembolism, osteoporosis, menopause, history of current rib or sternal or clavicle fractures, will be excluded. All eligible patients will enter the study and will receive general anesthesia and intubation according to treating doctors' decision.
Patients will be ventilated mechanically for 5 minutes to establish stable conditions. A pneumotachograph will be then connected to the ventilatory circuit so that respiratory efforts (volume, airway pressure and flow) can be continuously monitored at real time.
An esophageal catheter will be then inserted to monitor esophageal pressures and to provide data for lung mechanics calculation. Following the above procedures and before any surgical procedure, chest compressions will be performed to the patient by a senior anesthesiologist according to ERC guidelines of 2010 for 30 seconds.
Following chest compressions, patients will be evaluated for possible complications and after the establishment of stable conditions surgical procedures will follow. After the end of the surgical operation clinical and chest ultrasound evaluation will be performed.
Written inform consent will be obtained by all patients before procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Cardiopulmonary resuscitation chest compressionsCardiopulmonary resuscitation with measurement of tidal volume, airway pressure and flow by a pneumotachograph and airway, oesophageal pressure sensors |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-55 years
- ASA I-II
- candidates for surgical operation who will receive general anesthesia
Key exclusion criteria (6 listed)
- surgical operation in the chest
- musculoskeletal diseases
- cardiopulmonary or vascular acute or chronic diseases
- history of pneumothorax
- thromboembolism
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 |
|---|---|---|
| Cardiopulmonary resuscitation chest compressions | Other | Patients |
Primary outcome
Tidal volume during cardiopulmonary resuscitation
Time frame: 30 seconds
Tidal volume will be assessed by a pneumotachograph (Hans Rudolf USA)
2 secondary outcomes
Esophageal pressures during cardiopulmonary resuscitation
Time frame: 30 seconds
Lung compliance before and at the end of cardiopulmonary resuscitation
Time frame: 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Related trials for Ventilation During Cardiopulmonary Resuscitation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Not yet recruiting
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
Cardiac Arrest
RecruitingObservational study
The Ventilation During In-hospital Cardiac Arrest Study
Cardiac Arrest (CA), In-Hospital Cardiac Arrest
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiopulmonary resuscitation chest compressions in people with Ventilation During Cardiopulmonary Resuscitation, run by University of Thessaly at 1 site in Greece.
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 3 inclusion and 6 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 May 2017. 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 Greece. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume during cardiopulmonary resuscitation (time frame: 30 seconds). 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 May 2017.