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Monitoring of Intubation and Ventilation During Resuscitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204217
First Posted: September 20, 2005
Last Update Posted: August 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation
University of Stavanger
Information provided by:
University of Oslo
  Purpose
Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac arrest. Endotracheal intubation is the gold standard for airway control, but several studies have shown high rates of unrecognized placements of the tube in the esophagus instead of in the airway out-of-hospital. This is lethal. There are no failproof technique for recognising such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the lungs with ventilation changes the impedance (resistance to alternating current) through the thorax. This impedance is already measured routinely by the defibrillators used during CPR. We propose that we can measure ventilation volumes and also discover failed intubations by monitoring this impedance during CPR with the possibility of giving feedback on both to the rescuers.

Condition Intervention Phase
Cardiac Arrest Device: endotracheal intubation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring of Intubation and Ventilation During Resuscitation

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • sensitivity/specificity for lung ventilation detection
  • correlation ventilation volume - impedance change

Estimated Enrollment: 15
Study Start Date: September 2004
Study Completion Date: April 2007
Detailed Description:
On the anesthesiologist manned ambulance in Oslo ventilation volumes during CPR will be controlled with a ventilator, the tidal volume varied in random order between 500, 700 and 100 ml, and the volumes be measured continuously as will the impedance between the defibrillator electrodes. In case of failed CPR, the patient will be declared dead. Thereafter the lungs will be ventilated with 700 ml followed by removal of the endotracheal tube, placement of an endotracheal tube in the esophagus and ventilation of this tube, again with monitoring of the impedance.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac arrest

Exclusion Criteria:

  • <18 years old trauma pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204217


Locations
Norway
Ulleval University Hospital
Oslo, Norway, N-0407
Sponsors and Collaborators
University of Oslo
Laerdal Medical
Ullevaal University Hospital
Health Region East, Norway
Norwegian Air Ambulance Foundation
University of Stavanger
Investigators
Principal Investigator: Elizabeth Dorph Ulleval University Hospital, University of Oslo
  More Information

ClinicalTrials.gov Identifier: NCT00204217     History of Changes
Other Study ID Numbers: 313-04124
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by University of Oslo:
cardiac arrest
resuscitation
ventilation
impedance

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases