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Completed

NCT Number: NCT03347175

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

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.

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Key information

Conditions

Cardiopulmonary Resuscitation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

volume controlled ventilation

Procedure

Volume controlled ventilation mode

Pressure Controlled Ventilation

Procedure

Pressure controlled ventilation

CPAP mode

Procedure

CPAP mode only

Primary outcomes

  1. mean tidal volume

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    mean tidal volume during the study period

Secondary outcomes

  1. mean minute volume

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    mean minute volume during the study period

  2. etCO2

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    Mean, final value and course of the parameter during the study period

Other outcomes

  1. paO2

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    Mean, final value and course of the parameter during the study period

  2. paCO2

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    Mean, final value and course of the parameter during the study period

  3. Ventilation setting change

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    We will assess changes made in the ventilator settings (mode, tidal volume, frequency, FiO2 and PEEP) during the study period

  4. Ventilation setting change lateron

    Time frame: Starting after the end of Study Period (15 min after randomized ventilation mode was activated) till cardiopulmonary resuscitation is stopped by the treating team

    We will assess changes made in the ventilator settings (mode, tidal volume, frequency, FiO2 and PEEP) after study period until the end of CPR

  5. Ventilation hours

    Time frame: Starting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; ; approximately 3 weeks

    Ventilation hours in the hospital

  6. 24h Survival

    Time frame: 24h after randomization

    Survival 24h after randomization

  7. Hospital Survival/Mortality

    Time frame: Starting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; approximately 3 weeks

    Hospital Survival/Mortality

  8. BGA

    Time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

    Blood gas analysis

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: COVME

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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