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

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: Completed
• Conditions: Cardiopulmonary Resuscitation
• Intervention / Treatment: Procedure: Volume controlled ventilation; Procedure: Pressure controlled ventilation; Procedure: CPAP mode

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
mean tidal volume	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

Outcome Measure	Measure Description	Time Frame
mean minute volume	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	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

Outcome Measure	Measure Description	Time Frame
paO2	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	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	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	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	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	Survival 24h after randomization	24h after randomization
Hospital Survival/Mortality	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	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

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Stefan J Schaller, MD, Klinik für Anaesthesiologie

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Emergency Service, Hospital; Respiration, Artificial; Advanced Cardiac Life Support; Heart Massage
• Other Study ID 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