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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03347175
Acronym
COVME
Enrollment
30
Registered
2017-11-20
Start date
2017-11-06
Completion date
2019-12-12
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Resuscitation

Keywords

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

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.

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.

Interventions

Pressure controlled ventilation

PROCEDURECPAP mode

CPAP mode only

Volume controlled ventilation mode

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
mean tidal volumeStudy 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

MeasureTime frameDescription
mean minute volumeStudy 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
etCO2Study 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

MeasureTime frameDescription
Ventilation setting change lateronStarting after the end of Study Period (15 min after randomized ventilation mode was activated) till cardiopulmonary resuscitation is stopped by the treating teamWe will assess changes made in the ventilator settings (mode, tidal volume, frequency, FiO2 and PEEP) after study period until the end of CPR
Ventilation hoursStarting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; ; approximately 3 weeksVentilation hours in the hospital
paO2Study 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
Hospital Survival/MortalityStarting point = Activation of randomized ventilation mode till End point = time when patient is discharged from the hospital; approximately 3 weeksHospital Survival/Mortality
BGAStudy period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)Blood gas analysis
24h Survival24h after randomizationSurvival 24h after randomization
paCO2Study 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 changeStudy 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026