Clinical trial NCT04237727: CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study
Official title: CAvent-Ventilation During Advanced Cardiopulmonary Resuscitation in Out-of-hospital Cardiac Arrest- a Descriptive Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-of-Hospital Cardiac Arrest
Pulmonary Ventilation
Keywords: Out-of-Hospital Cardiac Arrest
Cardiopulmonary Resuscitation
Respiration, Artificial
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Regionale Ambulance Voorziening, Amersfoort, Utrecht, Netherlands
First posted: 2020-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be patients who have suffered an OHCA with CPR started by EMS personnel in Uppsala; Sweden and Utrech, Amersfoort; Holland.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ventilation frequency
timeFrame: From start of CPR to end of CPR.
measure: Tidal volume
timeFrame: From start of CPR to end of CPR.
measure: Minute Ventilation
timeFrame: From start of CPR to end of CPR.
Secondary outcomes:
measure: Variation of etCO2 in relation to different ratios of compression to ventilations
timeFrame: From start of CPR to end of CPR.
measure: Time of inspiration
timeFrame: From start to end of CPR.
measure: Fraction of dead space ventilation
timeFrame: From start of CPR to end of CPR..
measure: Peak inspiratory pressure during ventilation
timeFrame: From start of CPR to end of CPR.
measure: Survival rate
timeFrame: 30 days post cardiac arrest
measure: Neurological outcome
timeFrame: 30 days post cardiac arrest
measure: Neurological outcome
timeFrame: 30 days post cardiac arrest.
measure: Survival rate
timeFrame: 6 months post cardiac arrest
measure: Neurological outcome
timeFrame: 6 months post cardiac arrest
measure: Neurological outcome
timeFrame: 6 months post cardiac arrest.
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Regionale Ambulance Voorziening Utrecht, Netherlands
state: Utrecht
city: Uppsala
country: Sweden
facility: Uppsala University hospital
Study officials:
affiliation: Uppsala University department of surgical sciences
name: Sten Rubertsson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University department of surgical sciences
name: David Smekal, PhD
role: STUDY_CHAIR
affiliation: Uppsala University department of surgical sciences
name: Johan Mällberg, BsSC
role: STUDY_CHAIR
affiliation: Regionale Ambulance Voorziening Utrecht (RAVU)
name: René Boomars, MSc
role: STUDY_CHAIR
affiliation: Regionale Ambulance Voorziening Utrecht (RAVU)
name: Thijs Verhagen, MD
role: STUDY_CHAIR
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