CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study

Sponsor
Uppsala University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04237727
Collaborator
Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands (Other)
200
2
33.1
100
3

Study Details

Study Description

Brief Summary

The aim with this descriptive multicenter study is to examine the quality of the ventilation given by Emergency Medical Service (EMS) personnel during cardiopulmonary resuscitation (CPR).

Primary endpoint is the ventilation quality measured as ventilation frequency, tidal volume and minute ventilation.

This will primarily be studied during CPR with a 30 compression/2 ventilation ratio performed by the EMS personnel where the airway is managed with a supraglottic device but also in CPR with continuous ventilation (8-10 breaths/minute) after the airway management have been replaced with an endotracheal within the emergency room.

The inclusion of patients will be performed at two sites (Uppsala; Sweden and Utrecht; Holland), all out-of-hospital cardia arrest (OHCA) patients will receive care according to current CPR guidelines using mechanical chest compressions.

Condition or Disease Intervention/Treatment Phase
  • Device: Fluxmed GrH will be used to measure the ventilation parameters

Detailed Description

The inclusion is estimated to run over a two-year period to reach the goal of at least 200 patients. The study has been preceded by a trial period in an effort to solve any logistic and technical problems.

The study will be a prospective descriptive multicenter study where measurement of ventilation data will be sampled during CPR by EMS treating patients with OHCA. Any results from standard laboratory tests related to ventilation quality will be retracted from the patient medical journal systems. In addition to ventilatory variables measured as endpoints, secondary endpoints will also be outcome measures as any ROSC, survival and neurological outcome (mRS, GOS-E) measured at 30 days and at 6 months.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study
Actual Study Start Date :
Mar 29, 2019
Anticipated Primary Completion Date :
Mar 25, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Ventilation frequency [From start of CPR to end of CPR.]

    Measured as ventilations per minute.

  2. Tidal volume [From start of CPR to end of CPR.]

    Measured as milliliters per ventilation.

  3. Minute Ventilation [From start of CPR to end of CPR.]

    Measured as litres per minute.

Secondary Outcome Measures

  1. Variation of etCO2 in relation to different ratios of compression to ventilations [From start of CPR to end of CPR.]

    etCO2 measured as kilopascal for each exhalation during CPR with 30 compressions and 2 ventilations and during continous compressions and ventilations.

  2. Time of inspiration [From start to end of CPR.]

    Measured as seconds for each inspiration.

  3. Fraction of dead space ventilation [From start of CPR to end of CPR..]

    Dead space measured as milliliters for each ventilation compared to the tidal volume in milliters for that same ventilation.

  4. Peak inspiratory pressure during ventilation [From start of CPR to end of CPR.]

    Measured as cmH20 for each ventilation.

  5. Survival rate [30 days post cardiac arrest]

    Number of patients that has survived after the cardiac arrest.

  6. Neurological outcome [30 days post cardiac arrest]

    Measured with the modified Ranking Scale (mRS).

  7. Neurological outcome [30 days post cardiac arrest.]

    Measured with the Glascow Outcome Scale -Extended (GOS-E).

  8. Survival rate [6 months post cardiac arrest]

    Number of patients that has survived after the cardiac arrest..

  9. Neurological outcome [6 months post cardiac arrest]

    Measured with the modified Ranking Scale (mRS).

  10. Neurological outcome [6 months post cardiac arrest.]

    Measured with the Glascow Outcome Scale -Extended (GOS-E).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

Out-of-hospital cardiac arrest (OHCA) treated with CPR performed by the EMS personnel

Exclusion Criteria:
  • Patient age < 18 years

  • Known pregnancy

  • Trauma related cardiac arrest (inc. hanging)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regionale Ambulance Voorziening Utrecht, Netherlands Amersfoort Utrecht Netherlands
2 Uppsala University hospital Uppsala Sweden 75185

Sponsors and Collaborators

  • Uppsala University
  • Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands

Investigators

  • Principal Investigator: Sten Rubertsson, PhD, Uppsala University department of surgical sciences
  • Study Chair: David Smekal, PhD, Uppsala University department of surgical sciences
  • Study Chair: Johan Mällberg, BsSC, Uppsala University department of surgical sciences
  • Study Chair: René Boomars, MSc, Regionale Ambulance Voorziening Utrecht (RAVU)
  • Study Chair: Thijs Verhagen, MD, Regionale Ambulance Voorziening Utrecht (RAVU)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sten Rubertsson, Professor, Uppsala University
ClinicalTrials.gov Identifier:
NCT04237727
Other Study ID Numbers:
  • VENT001
First Posted:
Jan 23, 2020
Last Update Posted:
Feb 19, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sten Rubertsson, Professor, Uppsala University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2020