- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420483
Lung Ventilation During Cardiopulmonary Resuscitation
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
-
Larissa, Thessaly, Greece, 41110
- Recruiting
- Uh Larissa
-
Contact:
- KONSTANTINOS PRATSAS, MD
- Phone Number: +30 2413501351
- Email: konvol1@gmail.com
-
Contact:
- DEMETRA BAGKA, MD
- Phone Number: +30241302964
- Email: dbagka@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-55 years
- ASA I-II
- candidates for surgical operation who will receive general anesthesia
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
Cardiopulmonary resuscitation with measurement of tidal volume, airway pressure and flow by a pneumotachograph and airway, oesophageal pressure sensors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tidal volume during cardiopulmonary resuscitation
Time Frame: 30 seconds
|
Tidal volume will be assessed by a pneumotachograph (Hans Rudolf USA)
|
30 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Esophageal pressures during cardiopulmonary resuscitation
Time Frame: 30 seconds
|
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.
|
30 seconds
|
Lung compliance before and at the end of cardiopulmonary resuscitation
Time Frame: 30 seconds
|
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.
|
30 seconds
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 49304 11/11/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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