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CompletedNCT03347175COVMEUpdated Feb 6, 2020

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

An interventional study of Volume controlled ventilation and Pressure controlled ventilation in Cardiopulmonary Resuscitation, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cardiopulmonary Resuscitation

Keywords

  • Respiration, Artificial
  • Advanced Cardiac Life Support
  • Heart Massage
  • Emergency Service, Hospital
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • If the treating team assumes that CPR will be ceased within the next 15 minutes
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Volume controlled ventilation

    Intervention1: Ventilation with Volume controlled ventilation

    Procedure: Volume controlled ventilation

  • Active comparator
    Pressure controlled ventilation

    Intervention2: Ventilation with Pressure controlled ventilation

    Procedure: Pressure controlled ventilation

  • Active comparator
    CPAP mode

    Intervention3: Ventilation with Continuous Positive Airway Pressure mode only

    Procedure: CPAP mode

Interventions

  • ProcedureVolume controlled ventilation

    Volume controlled ventilation mode

  • ProcedurePressure controlled ventilation

    Pressure controlled ventilation

  • ProcedureCPAP mode

    CPAP mode only

05

What researchers measure

Primary outcomes

  1. mean tidal volume

    mean tidal volume during the study period

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

Secondary outcomes

  1. mean minute volume

    mean minute volume during the study period

    Time frame: 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

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

Other outcomes

  1. paO2

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

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

  2. paCO2

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

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

  3. Ventilation setting change

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

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

  4. Ventilation setting change lateron

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

    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

  5. Ventilation hours

    Ventilation hours in the hospital

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

  6. 24h Survival

    Survival 24h after randomization

    Time frame: 24h after randomization

  7. Hospital Survival/Mortality

    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

  8. BGA

    Blood gas analysis

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

06

Study locations

1 site
  • Klinikum rechts der Isar
    Munich, Bavaria 81675, Germany
07

References and documents

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 ↗

Individual participant data

Plan to share: No — We are willing to share anonymized and aggregated data for meta analysis or on an individual decision to collaboration partners.

08

Registry details

Key details

Study ID
NCT03347175
Lead sponsor
Technical University of Munich
Responsible party
Stefan Schaller (Principal Investigator, Technical University of Munich) — Principal investigator
First posted
Nov 20, 2017
Start date
Nov 6, 2017
Primary completion
Dec 12, 2019
Completion
Dec 12, 2019
Last update
Feb 6, 2020

Study contacts

Stefan J Schaller, MD
principal investigator · Klinik für Anaesthesiologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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