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Monitoring of Intubation and Ventilation During Resuscitation

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
endotracheal intubation
Sponsored by
University of Oslo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Arrest focused on measuring cardiac arrest, resuscitation, ventilation, impedance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cardiac arrest Exclusion Criteria: <18 years old trauma pregnancy

Sites / Locations

  • Ulleval University Hospital

Outcomes

Primary Outcome Measures

sensitivity/specificity for lung ventilation detection
correlation ventilation volume - impedance change

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
August 24, 2007
Sponsor
University of Oslo
Collaborators
Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, University of Stavanger
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1. Study Identification

Unique Protocol Identification Number
NCT00204217
Brief Title
Monitoring of Intubation and Ventilation During Resuscitation
Official Title
Monitoring of Intubation and Ventilation During Resuscitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo
Collaborators
Laerdal Medical, Ullevaal University Hospital, Health Region East, Norway, Norwegian Air Ambulance Foundation, University of Stavanger

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, resuscitation, ventilation, impedance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
endotracheal intubation
Primary Outcome Measure Information:
Title
sensitivity/specificity for lung ventilation detection
Title
correlation ventilation volume - impedance change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiac arrest Exclusion Criteria: <18 years old trauma pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Dorph
Organizational Affiliation
Ulleval University Hospital, University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulleval University Hospital
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway

12. IPD Sharing Statement

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Monitoring of Intubation and Ventilation During Resuscitation

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