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Cardiopulmonary ResuscitationCOVMENCT03347175

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

A study testing CPAP mode in people with Cardiopulmonary Resuscitation, run by Technical University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiopulmonary Resuscitation
What is being tested?
CPAP mode
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
6 Nov 2017to 12 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • On-going out of hospital CPR in the Emergency Room
  • Tracheal intubated
  • Use of mechanical chest compression device

Who cannot join

  • If the treating team assumes that CPR will be ceased within the next 15 minutes

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum rechts der Isar

    Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Volume controlled ventilation, Pressure controlled ventilation, CPAP mode
Keywords
Respiration, Artificial, Advanced Cardiac Life Support, Heart Massage, Emergency Service, Hospital
Medical subject headings
Respiratory Aspiration, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Volume controlled ventilationProcedure or surgery

    Volume controlled ventilation mode

  • Pressure controlled ventilationProcedure or surgery

    Pressure controlled ventilation

  • CPAP modeProcedure or surgery

    CPAP mode only

Study groups in NCT03347175
Study groupRoleWhat they receive
Volume controlled ventilationExperimentalIntervention1: Ventilation with Volume controlled ventilation
Receives: Procedure: Volume controlled ventilation
Pressure controlled ventilationActive comparatorIntervention2: Ventilation with Pressure controlled ventilation
Receives: Procedure: Pressure controlled ventilation
CPAP modeActive comparatorIntervention3: Ventilation with Continuous Positive Airway Pressure mode only
Receives: Procedure: CPAP mode

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mean tidal volume

    mean tidal volume during the study period

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

Secondary outcomes (2)

  1. mean minute volume

    mean minute volume during the study period

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

  2. etCO2

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2017
  2. Study start6 Nov 2017
  3. Primary completion12 Dec 2019
  4. Study completion12 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03347175
Sponsor's protocol ID
COVME
Acronym
COVME
Status last verified
Feb 2020
First submitted
24 Oct 2017
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are willing to share anonymized and aggregated data for meta analysis or on an individual decision to collaboration partners.

Publications

  • Bernhard M, Hossfeld B, Kumle B, Becker TK, Bottiger B, Birkholz T. Don't forget to ventilate during cardiopulmonary resuscitation with mechanical chest compression devices. Eur J Anaesthesiol. 2016 Aug;33(8):553-6. doi: 10.1097/EJA.0000000000000426. No abstract available.

    PubMed 26854661

  • Hillman K, Albin M. Pulmonary barotrauma during cardiopulmonary resuscitation. Crit Care Med. 1986 Jul;14(7):606-9. doi: 10.1097/00003246-198607000-00003.

    PubMed 3720308

  • Shulman D, Beilin B, Olshwang D. Pulmonary barotrauma during cardiopulmonary resuscitation. Resuscitation. 1987 Sep;15(3):201-7. doi: 10.1016/0300-9572(87)90015-3.

    PubMed 2823358

  • Hou SH, Lue HC, Chu SH. Comparison of conventional and simultaneous compression-ventilation cardiopulmonary resuscitation in piglets. Jpn Circ J. 1994 Jun;58(6):426-32. doi: 10.1253/jcj.58.426.

    PubMed 8065014

  • Kleinsasser A, Lindner KH, Schaefer A, Loeckinger A. Decompression-triggered positive-pressure ventilation during cardiopulmonary resuscitation improves pulmonary gas exchange and oxygen uptake. Circulation. 2002 Jul 16;106(3):373-8. doi: 10.1161/01.cir.0000021428.94652.04.

    PubMed 12119256

  • Kill C, Hahn O, Dietz F, Neuhaus C, Schwarz S, Mahling R, Wallot P, Jerrentrup A, Steinfeldt T, Wulf H, Dersch W. Mechanical ventilation during cardiopulmonary resuscitation with intermittent positive-pressure ventilation, bilevel ventilation, or chest compression synchronized ventilation in a pig model. Crit Care Med. 2014 Feb;42(2):e89-95. doi: 10.1097/CCM.0b013e3182a63fa0.

    PubMed 24158168

  • Winkler BE, Muellenbach RM, Wurmb T, Struck MF, Roewer N, Kranke P. Passive continuous positive airway pressure ventilation during cardiopulmonary resuscitation: a randomized cross-over manikin simulation study. J Clin Monit Comput. 2017 Feb;31(1):93-101. doi: 10.1007/s10877-016-9836-6. Epub 2016 Feb 9.

    PubMed 26861639

  • Kill C, Galbas M, Neuhaus C, Hahn O, Wallot P, Kesper K, Wulf H, Dersch W. Chest Compression Synchronized Ventilation versus Intermitted Positive Pressure Ventilation during Cardiopulmonary Resuscitation in a Pig Model. PLoS One. 2015 May 26;10(5):e0127759. doi: 10.1371/journal.pone.0127759. eCollection 2015.

    PubMed 26011525

  • Tan D, Xu J, Shao S, Fu Y, Sun F, Zhang Y, Hu Y, Walline J, Zhu H, Yu X. Comparison of different inspiratory triggering settings in automated ventilators during cardiopulmonary resuscitation in a porcine model. PLoS One. 2017 Feb 10;12(2):e0171869. doi: 10.1371/journal.pone.0171869. eCollection 2017.

    PubMed 28187154

Questions about this trial

What is this clinical trial studying?

A study testing CPAP mode in people with Cardiopulmonary Resuscitation, run by Technical University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean tidal volume (time frame: Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03347175, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.

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