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

Recruiting

• Conditions: Pulmonary Ventilation; Out-of-Hospital Cardiac Arrest

• Registration Number: NCT04237727
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2019-03-29
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-21
• Primary Completion: 2024-12-25
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tidal volume	From start of CPR to end of CPR.	Measured as milliliters per ventilation.
Minute Ventilation	From start of CPR to end of CPR.	Measured as litres per minute.
Ventilation frequency	From start of CPR to end of CPR.	Measured as ventilations per minute.

Secondary Outcome Measures

Name	Time	Method
Survival rate	6 months post cardiac arrest	Number of patients that has survived after the cardiac arrest..
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.
Neurological outcome	6 months post cardiac arrest.	Measured with the Glascow Outcome Scale -Extended (GOS-E).
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.
Peak inspiratory pressure during ventilation	From start of CPR to end of CPR.	Measured as cmH20 for each ventilation.
Time of inspiration	From start to end of CPR.	Measured as seconds for each inspiration.

Trial Locations

Locations (2)

Uppsala University hospital; 🇸🇪 Uppsala, Sweden

Regionale Ambulance Voorziening Utrecht, Netherlands; 🇳🇱 Amersfoort, Utrecht, Netherlands