Monitoring of Intubation and Ventilation During Resuscitation
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | August 24, 2007 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00204217 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monitoring of Intubation and Ventilation During Resuscitation | ||||
| Official Title ICMJE | Monitoring of Intubation and Ventilation During Resuscitation | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Cardiac Arrest | ||||
| Intervention ICMJE | Device: endotracheal intubation | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 15 | ||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00204217 | ||||
| Other Study ID Numbers ICMJE | 313-04124 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Oslo | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Oslo | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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