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

NCT ID: NCT03347175

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-12-12

Brief Summary

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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

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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.

Conditions

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Cardiopulmonary Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Volume controlled ventilation

Intervention1: Ventilation with Volume controlled ventilation

Group Type EXPERIMENTAL

Volume controlled ventilation

Intervention Type PROCEDURE

Volume controlled ventilation mode

Pressure controlled ventilation

Intervention2: Ventilation with Pressure controlled ventilation

Group Type ACTIVE_COMPARATOR

Pressure controlled ventilation

Intervention Type PROCEDURE

Pressure controlled ventilation

CPAP mode

Intervention3: Ventilation with Continuous Positive Airway Pressure mode only

Group Type ACTIVE_COMPARATOR

CPAP mode

Intervention Type PROCEDURE

CPAP mode only

Interventions

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Volume controlled ventilation

Volume controlled ventilation mode

Intervention Type PROCEDURE

Pressure controlled ventilation

Pressure controlled ventilation

Intervention Type PROCEDURE

CPAP mode

CPAP mode only

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Stefan Schaller

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan J Schaller, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anaesthesiologie

Locations

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Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 26854661 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3720308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2823358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8065014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12119256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24158168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26861639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26011525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28187154 (View on PubMed)

Other Identifiers

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COVME

Identifier Type: -

Identifier Source: org_study_id

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