NCT03347175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

October 24, 2017

Last Update Submit

February 5, 2020

Conditions

Cardiopulmonary Resuscitation

Keywords

Respiration, ArtificialAdvanced Cardiac Life SupportHeart MassageEmergency Service, Hospital

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • mean minute volume

    Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

  • etCO2

    Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

Other Outcomes (8)

  • paO2

    Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

  • paCO2

    Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

  • Ventilation setting change

    Study period = 15 min (Startpoint = Activating randomized ventilation mode Endpoint = 15 minutes after Starting point or end of CPR)

  • +5 more other outcomes

Study Arms (3)

Volume controlled ventilation

EXPERIMENTAL

Intervention1: Ventilation with Volume controlled ventilation

Procedure: Volume controlled ventilation

Pressure controlled ventilation

ACTIVE COMPARATOR

Intervention2: Ventilation with Pressure controlled ventilation

Procedure: Pressure controlled ventilation

CPAP mode

ACTIVE COMPARATOR

Intervention3: Ventilation with Continuous Positive Airway Pressure mode only

Procedure: CPAP mode

Interventions

Volume controlled ventilationPROCEDURE

Volume controlled ventilation mode

Volume controlled ventilation
Pressure controlled ventilationPROCEDURE

Pressure controlled ventilation

Pressure controlled ventilation
CPAP modePROCEDURE

CPAP mode only

CPAP mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On-going out of hospital CPR in the Emergency Room
  • Tracheal intubated
  • Use of mechanical chest compression device

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Related Publications (9)

  • 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.

    PMID: 26854661BACKGROUND

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

    PMID: 3720308BACKGROUND

  • 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.

    PMID: 2823358BACKGROUND

  • 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.

    PMID: 8065014BACKGROUND

  • 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.

    PMID: 12119256BACKGROUND

  • 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.

    PMID: 24158168BACKGROUND

  • 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.

    PMID: 26861639BACKGROUND

  • 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.

    PMID: 26011525BACKGROUND

  • 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.

    PMID: 28187154BACKGROUND

MeSH Terms

Conditions

Respiratory AspirationEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Stefan J Schaller, MD

    Klinik für Anaesthesiologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 20, 2017

Study Start

November 6, 2017

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

We are willing to share anonymized and aggregated data for meta analysis or on an individual decision to collaboration partners.

Locations

DE(1)