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Ventilation in Cardiac Arrest (VICA)

Primary Purpose

Cardio Respiratory Arrest, Cardiac Death, Ventilation Therapy; Complications

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
mechanical ventilation
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardio Respiratory Arrest focused on measuring cardiopulmonary resuscitation, mechanical ventilation, Gas exchange

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • out-of-hospital cardiac arrest (OHCA)
  • cardio-pulmonary resuscitation (CPR) efforts
  • endotracheal intubation

Exclusion Criteria:

  • children and adolescents (age<18 years at inclusion)
  • pregnant women
  • previous documented lack of legal capacity
  • previous documented refusal to participate in trials

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Alternative Ventilation Rate

Conventional Ventilation Rate

Arm Description

ventilation is performed at 20 breaths/min

ventilation is performed at 10 breaths/min

Outcomes

Primary Outcome Measures

Minute ventilation
exspiratory ventilatory volume per minute
adequacy of ventilation - pH
Evaluation of ventilation success per using arterial blood gas analyses (pH)
adequacy of ventilation - paCO2
Evaluation of ventilation success per using arterial blood gas analyses (paCO2)

Secondary Outcome Measures

ROSC
Return of Spontaneous Circulation

Full Information

First Posted
December 1, 2020
Last Updated
November 22, 2022
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04657393
Brief Title
Ventilation in Cardiac Arrest
Acronym
VICA
Official Title
Prospective Comparison of Ventilation Patterns During Cardio-Pulmonary Resuscitation for Out-Of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
slow inclusion
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Over the last decades, research in cardiopulmonary resuscitation was primarily focused on uninterrupted chest compressions to restore sufficient circulation. Ventilation during ongoing chest compressions was regarded as potentially deleterious and thus not given any major scientific focus. Current guidelines advise that ventilation be monitored by end-tidal CO2 and emphasize that hyperventilation be avoided. Recent findings from arterial blood gas analyses showed high levels of arterial pCO2, resulting in a frequent occurrence of hypercapnic acidosis, which may be caused by iatrogenic hypoventilation. Ventilation during ongoing chest compressions can be hard to achieve, as nearly every breath may be terminated by simultaneous chest compressions. In case of bag ventilation the applied tidal volumes have not yet been measured und mechanical ventilators so far were not able to ventilate during chest compressions, because pressure limit settings induced termination of inspiration. The aim of this study is to provide patients with the best possible ventilation, even under ongoing chest compressions. Patients are ventilated with a new turbine-driven ventilator (Monnal T60, Air Liquide, France), which can deliver adequate tidal volumes within a very short inspiratory phase due to the inspiratory flow of > 200l/min. Thus, in deviation from the current recommendations, the ventilation rate can be doubled to 20/min, so that inspiration coincides with cardiac massage less often. The study compares effective ventilation volumes applied by two regimes, 10 breaths/min and 20/min.
Detailed Description
Restoration of circulation is undoubtedly the basis of success in cardiopulmonary resuscitation (CPR). Current guidelines on CPR require that hyperventilation be avoided during CPR. Blood gas analysis results from the "BABICA trial" demonstrate that more than 90% of patients have highly elevated levels of pCO2 and are acidotic, mainly due to hypercapnia. No hyperventilated or alkalotic patients were found during CPR. Furthermore, higher pO2 values were found to be associated with improved outcomes. Current recommendations to limit ventilation frequency to 10/min was also critically questioned in a recent study from Belgium, which did not show any positive effect of low respiration rate compared to higher ones, cut-off 10/min. There are currently no clinical trials addressing optimal tidal volumes or minute volumes during CPR. A major obstacle to continuous measurement of respiratory minute volumes during CPR are ongoing chest compressions. In a retrospective study in which respiratory volumes were derived from bioimpedance curves, better outcomes were found in the group of more frequent ventilations. Common machine ventilators display set values, while expiratory volumes are averaged and may be overlaid by volume shifts of cardiac massage. In a recent study, investigators analyzed flow curves, where each breath can be evaluated individually and volumes can be derived correctly using dedicated software. We were able to test this method on a comparative study of three ventilators study on anatomical cadavers. This study aims to detect whether a higher rate of ventilation using a turbine driven ventilator is able to provide higher breathing volumes during ongoing chest compressions in individuals suffering from out-of-hospital cardiac arrest (OHCA). Higher ventilation and oxygenation parameters as well as optimized acid-base-balance and increased rates of ROSC are expected. Patient care (chest compressions, venous access, endotracheal intubation, application of drugs, defibrillation if necessary) is conducted according to current recommendation for Advanced Life Support (ALS) as issued by the European Resuscitation Council (ERC). Ventilation is performed at one of two patterns: the control group is ventilated at 10 breaths per minute, the intervention group is ventilated at 20 breaths per minute. Patterns are alternating according to calendar week. After successful endotracheal intubation mechanical ventilation is carried out using a turbine-driven ventilator (Monnal T60, AirLiquide, France). Ventilator settings are pre-set: respiratory frequency is set at 10/min or 20/min (see above), other ventilator parameters remain identical: Positive End-Expiratory Pressure (PEEP) 0 mmHg, FiO2 1,0, tidal volume 6ml/kg ideal body weight [men: 50+(0.91x(body length-152.4)), women: 45+(0.91y(body length-152.4))]. These calculations can be performed on the ventilator itself by entering patients' age, height and gender. Chest compressions are carried out without interruptions and without considerations regarding the respiratory cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio Respiratory Arrest, Cardiac Death, Ventilation Therapy; Complications, Apnea
Keywords
cardiopulmonary resuscitation, mechanical ventilation, Gas exchange

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, parallel study
Masking
Participant
Masking Description
randomizing the study groups
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternative Ventilation Rate
Arm Type
Active Comparator
Arm Description
ventilation is performed at 20 breaths/min
Arm Title
Conventional Ventilation Rate
Arm Type
Active Comparator
Arm Description
ventilation is performed at 10 breaths/min
Intervention Type
Procedure
Intervention Name(s)
mechanical ventilation
Intervention Description
change of ventilation frequency
Primary Outcome Measure Information:
Title
Minute ventilation
Description
exspiratory ventilatory volume per minute
Time Frame
during ongoing chest compressions
Title
adequacy of ventilation - pH
Description
Evaluation of ventilation success per using arterial blood gas analyses (pH)
Time Frame
during ongoing cardiopulmonary resuscitation
Title
adequacy of ventilation - paCO2
Description
Evaluation of ventilation success per using arterial blood gas analyses (paCO2)
Time Frame
during ongoing cardiopulmonary resuscitation
Secondary Outcome Measure Information:
Title
ROSC
Description
Return of Spontaneous Circulation
Time Frame
during prehospital resuscitation efforts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: out-of-hospital cardiac arrest (OHCA) cardio-pulmonary resuscitation (CPR) efforts endotracheal intubation Exclusion Criteria: children and adolescents (age<18 years at inclusion) pregnant women previous documented lack of legal capacity previous documented refusal to participate in trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Prause, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

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Ventilation in Cardiac Arrest

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