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NCT00204217 Clinical Trial

Monitoring of Intubation and Ventilation During Resuscitation

Cardiac Arrest Clinical Trial

Official title:
Monitoring of Intubation and Ventilation During Resuscitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204217
Other study ID # 313-04124
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated August 24, 2007
Start date September 2004
Est. completion date April 2007

Study information
Verified date August 2007
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cardiac arrest

Exclusion Criteria:

- <18 years old trauma pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• endotracheal intubation

Locations
Country Name City State
Norway Ulleval University Hospital Oslo

Sponsors (6)
Lead Sponsor Collaborator
University of Oslo Health Region East, Norway, Laerdal Medical, Norwegian Air Ambulance Foundation, Ullevaal University Hospital, University of Stavanger

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary sensitivity/specificity for lung ventilation detection
Primary correlation ventilation volume - impedance change
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