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

February 5, 2020 updated by: Stefan Schaller, Technical University of Munich

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum Rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Volume controlled ventilation
Intervention1: Ventilation with Volume controlled ventilation
Procedure: Volume controlled ventilation
Volume controlled ventilation mode
Active Comparator: Pressure controlled ventilation
Intervention2: Ventilation with Pressure controlled ventilation
Procedure: Pressure controlled ventilation
Pressure controlled ventilation
Active Comparator: CPAP mode
Intervention3: Ventilation with Continuous Positive Airway Pressure mode only
Procedure: CPAP mode
CPAP mode only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)
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
Starting after the end of Study Period (15 min after randomized ventilation mode was activated) till cardiopulmonary resuscitation is stopped by the treating team
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
Starting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; ; approximately 3 weeks
24h Survival
Time Frame: 24h after randomization
Survival 24h after randomization
24h after randomization
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
Starting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; approximately 3 weeks
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
Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefan J Schaller, MD, Klinik für Anaesthesiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are willing to share anonymized and aggregated data for meta analysis or on an individual decision to collaboration partners.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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