Pilot Study Comparing Ventilation Modes During CPR With Mechanical Compression Device.

Study Overview
=================
Brief Summary
-----------------
Comparison of three ventilation modes (volume controlled, BIPAP and CPAP) during cardiopulmonary re-suscitation with a mechanical compression device in the emergency room. Primary aim is to assess mean ventilation volume in the first 15 minutes after randomization.

Detailed Description
-----------------
Mechanical compression devices are applied to grant continuous chest compressions and consequently blood flow during CPR (cardiopulmonary rescuscitation). Current guidelines, however, are lacking guidance of the optimal ventilation strategy in such scenarios. This may lead to lung injuries caused by high pressure levels in the chest while applying compression and ventilation simultaneously or hypoventilation. Consequently, this pilot study assesses iwhich ventilation mode is optimal. Patients will be assigned randomly to one of the three ventilation modes (Volume controlled, BiPAP-ASB, CPAP). Ventilation parameters will be continuously monitored for 15 minutes while blood gas analyses are taken as well. Further secondary outcome parameters will be assessed, e.g. hospital mortality.

Official Title
-----------------
Pilot Study: Comparison of Ventilation Modes During Cardio-pulmonary Resuscitation With a Mechanical Compression Device in the Emergency Room

Conditions
-----------------
Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Procedure: Volume controlled ventilation
* Procedure: Pressure controlled ventilation
* Procedure: CPAP mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On-going out of hospital CPR in the Emergency Room Tracheal intubated Use of mechanical chest compression device Exclusion Criteria: If the treating team assumes that CPR will be ceased within the next 15 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volume controlled ventilation<br>Intervention1: Ventilation with Volume controlled ventilation | Procedure: Volume controlled ventilation<br>* Volume controlled ventilation mode<br>|
| Active Comparator: Pressure controlled ventilation<br>Intervention2: Ventilation with Pressure controlled ventilation | Procedure: Pressure controlled ventilation<br>* Pressure controlled ventilation<br>|
| Active Comparator: CPAP mode<br>Intervention3: Ventilation with Continuous Positive Airway Pressure mode only | Procedure: CPAP mode<br>* CPAP mode only<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean tidal volume | mean tidal volume during the study period | Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean minute volume | mean minute volume during the study period | Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR) | 
| etCO2 | Mean, final value and course of the parameter during the study period | Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiration, Artificial, Advanced Cardiac Life Support, Heart Massage, Emergency Service, Hospital