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

Not Applicable

Completed

• Conditions: Cardiopulmonary Resuscitation
• Interventions: Procedure: Pressure controlled ventilation; Procedure: Volume controlled ventilation; Procedure: CPAP mode

• Registration Number: NCT03347175
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study First Submitted: 2017-10-24
• Study Start: 2017-11-06
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-20
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure controlled ventilation	Pressure controlled ventilation	Intervention2: Ventilation with Pressure controlled ventilation
Volume controlled ventilation	Volume controlled ventilation	Intervention1: Ventilation with Volume controlled ventilation
CPAP mode	CPAP mode	Intervention3: Ventilation with Continuous Positive Airway Pressure mode only

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany