Lung Ventilation During Cardiopulmonary Resuscitation

May 2, 2017 updated by: DEMOSTHENES MAKRIS, University of Thessaly

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

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Recruiting
        • Uh Larissa
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

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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