COVME: Pilot Study Comparing Ventilation Modes During CPR With Mechanical Compression Device.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- mean tidal volume [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 Outcome Measures
- mean minute volume [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
- etCO2 [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 Outcome Measures
- paO2 [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
- paCO2 [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
- Ventilation setting change [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
- Ventilation setting change lateron [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
- Ventilation hours [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
- 24h Survival [24h after randomization]
Survival 24h after randomization
- Hospital Survival/Mortality [Starting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; approximately 3 weeks]
Hospital Survival/Mortality
- BGA [Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)]
Blood gas analysis
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum rechts der Isar | Munich | Bavaria | Germany | 81675 |
Sponsors and Collaborators
- Technische Universität München
Investigators
- Principal Investigator: Stefan J Schaller, MD, Klinik für Anaesthesiologie
Study Documents (Full-Text)
None provided.More Information
Publications
- Bernhard M, Hossfeld B, Kumle B, Becker TK, Böttiger 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.
- Hillman K, Albin M. Pulmonary barotrauma during cardiopulmonary resuscitation. Crit Care Med. 1986 Jul;14(7):606-9.
- 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.
- 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.
- 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.
- 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.
- Shulman D, Beilin B, Olshwang D. Pulmonary barotrauma during cardiopulmonary resuscitation. Resuscitation. 1987 Sep;15(3):201-7.
- 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.
- 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.
- COVME