Ventilation in Cardiac Arrest

NCT04657393 | Terminated

• 1 other identifier: VICA
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardio Respiratory Arrest; Cardiac Death; Ventilation Therapy; Complications; Apnea

Keywords

cardiopulmonary resuscitation; mechanical ventilation; Gas exchange

Outcome Measures

Primary Outcomes (3)

• Minute ventilation

  exspiratory ventilatory volume per minute

  during ongoing chest compressions

• adequacy of ventilation - pH

  Evaluation of ventilation success per using arterial blood gas analyses (pH)

  during ongoing cardiopulmonary resuscitation

• adequacy of ventilation - paCO2

  Evaluation of ventilation success per using arterial blood gas analyses (paCO2)

  during ongoing cardiopulmonary resuscitation

Secondary Outcomes (1)

• ROSC

  during prehospital resuscitation efforts

Study Arms (2)

Alternative Ventilation Rate

ACTIVE COMPARATOR

ventilation is performed at 20 breaths/min

Procedure: mechanical ventilation

Conventional Ventilation Rate

ACTIVE COMPARATOR

ventilation is performed at 10 breaths/min

Procedure: mechanical ventilation

Interventions

mechanical ventilation PROCEDURE

change of ventilation frequency

Alternative Ventilation Rate; Conventional Ventilation Rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnant women
• previous documented lack of legal capacity
• previous documented refusal to participate in trials

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (1)

• Prause G, Zoidl P, Eichinger M, Eichlseder M, Orlob S, Ruhdorfer F, Honnef G, Metnitz PGH, Zajic P. Mechanical ventilation with ten versus twenty breaths per minute during cardio-pulmonary resuscitation for out-of-hospital cardiac arrest: A randomised controlled trial. Resuscitation. 2023 Jun;187:109765. doi: 10.1016/j.resuscitation.2023.109765. Epub 2023 Mar 15.

  PMID: 36931453 DERIVED

MeSH Terms

Conditions

Heart Arrest; Death; Apnea

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• Gerhard Prause, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomizing the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized, parallel study

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: June 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

AU (1)