Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02420483
Other study ID # 49304 11/11/13
Secondary ID
Status Recruiting
Phase N/A
First received March 27, 2015
Last updated May 2, 2017
Start date December 2015
Est. completion date December 2018

Study information

Verified date May 2017
Source University of Thessaly
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Ventilation During Cardiopulmonary Resuscitation

Intervention

Other:
Cardiopulmonary resuscitation chest compressions


Locations

Country Name City State
Greece Uh Larissa Larissa Thessaly

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tidal volume during cardiopulmonary resuscitation Tidal volume will be assessed by a pneumotachograph (Hans Rudolf USA) 30 seconds
Secondary 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. 30 seconds
Secondary 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. 30 seconds