NCT06809309

Brief Summary

The goal of this prospective observational study is to learn how ventilation quality parameters during cardiopulmonary resuscitation (CPR) are associated with short-term survival following in-hospital cardiac arrest of adult patients. The main questions it aims to answer are: What ventilation volume during CPR is associated with the highest chance of return of spontaneous circulation (ROSC)? What ventilation rate during CPR is associated with the highest chance of ROSC? Researchers will compare different levels of ventilation rates and volumes that are blindly measured during CPR to see how the observed rates and volumes are associated with survival outcomes and complications.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
2 countries

11 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Feb 2025Jun 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

January 20, 2025

Last Update Submit

March 27, 2026

Conditions

Keywords

prospective observational studyventilationmanual ventilationcardiac arrestin-hospital cardiac arrest (IHCA)bag-valve-mask (BVM)tidal volumeventilation rateintra-arrest ventilationcardiopulmonary ventilation (CPR)resuscitationadult

Outcome Measures

Primary Outcomes (1)

  • Fraction of patients with return of spontaneous circulation (ROSC)

    ROSC is defined as sustained spontaneous circulation with no need for chest compressions for at least 20 minutes.

    ROSC is assessed immediately following cardiopulmonary resuscitation.

Secondary Outcomes (1)

  • Fraction of patients surviving until day 30

    Assessed at day 30 after cardiac arrest.

Other Outcomes (3)

  • Fraction of patients with pulmonary complications

    From date of ROSC until date of intensive care unit discharge or date of death from any cause, whichever came first, assessed up to 30 days.

  • Number of days alive without mechanical ventilation

    From date of ROSC until day 30 or date of death from any cause, whichever came first.

  • Number of days alive outside the intensive care unit

    From date of ROSC until day 90 or date of death from any cause, whichever came first.

Study Arms (1)

Study cohort

Adult patients (≥18 years) with in-hospital cardiac arrest receiving cardiopulmonary resuscitation. Groups will be defined based on observed distribution of ventilation parameters (ventilation rate, tidal volume and minute ventilation).

Other: Positive pressure ventilation during cardiopulmonary resuscitation

Interventions

The primary exposures of interest are the observed ventilation rate, tidal volume and minute ventilation during cardiopulmonary resuscitation. Ventilation data are obtained by inspiratory and expiratory air flow measurements using the EOlife (Archeon, Besançon, France) to which healthcare providers are blinded.

Also known as: manual ventilation, artificial ventilation, intra-arrest ventilation, bag-valve-mask ventilation, invasive ventilation
Study cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients receiving ventilation with a bag-valve-mask (BVM) or advanced airway during cardiopulmonary resuscitation for in-hospital cardiac arrest.

You may qualify if:

  • In-hospital cardiac arrest
  • Age ≥ 18 years
  • \>1minute of recorded ventilation data

You may not qualify if:

  • Documented do-not-attempt cardiopulmonary resuscitation order
  • Invasive mechanical circulatory support at the time of the cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital of Southern Jutland - Aabenraa

Aabenraa, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Hospital of Southwest Jutland - Esbjerg

Esbjerg, 6700, Denmark

RECRUITING

Gødstrup Hospital

Gødstrup, 7400, Denmark

RECRUITING

North Denmark Region Hospital - Hjørring

Hjørring, 9800, Denmark

RECRUITING

Horsens Regional Hospital

Horsens, 8700, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Randers Regional Hospital

Randers, 8930, Denmark

RECRUITING

Viborg Regional Hospital

Viborg, 8800, Denmark

RECRUITING

St. Olavs Hospital, Trondheim University Hospital

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Heart ArrestRespiratory Aspiration

Interventions

Respiration, ArtificialNoninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Johannes Wittig, MD

    Department of Clinical Medicine, Aarhus University, Denmark; Department of Medicine, Randers Regional Hospital, Randers, Denmark; Research Center for Emergency Medicine, Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR
  • Kasper G Lauridsen, MD, PhD

    Department of Clinical Medicine, Aarhus University, Denmark; Department of Medicine, Randers Regional Hospital, Randers, Denmark; Research Center for Emergency Medicine, Aarhus University Hospital, Denmark;

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasper G Lauridsen, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 5, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The investigators are not permitted to share IPD.

Locations