- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06809309
The Ventilation During In-hospital Cardiac Arrest Study (VENT-IHCA)
The Ventilation During In-Hospital Cardiac Arrest (VENT-IHCA) Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Johannes Wittig, MD
- Phone Number: +45 78 42 00 00
- Email: johannes.wittig@clin.au.dk
Study Contact Backup
- Name: Kasper G Lauridsen, MD, PhD
- Phone Number: +45 78 42 00 00
- Email: kglerup@clin.au.dk
Study Locations
-
-
-
Aabenraa, Denmark
- Recruiting
- Hospital of Southern Jutland - Aabenraa
-
Contact:
- Rajesh Prabhakar Bhavsar
- Phone Number: +45 79 97 00 00
- Email: rajesh.prabhakar.bhavsar@rsyd.dk
-
Aalborg, Denmark, 9000
- Recruiting
- Aalborg University Hospital
-
Contact:
- Thomas L Klitgaard
- Phone Number: +45 97 66 00 00
- Email: tlk@rn.dk
-
Contact:
- Steen Kåre Stokbro Fagerberg
- Phone Number: +45 97 66 00 00
- Email: s.fagerberg@rn.dk
-
Aarhus, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Kristian Krogh
- Phone Number: +45 7845 0000
- Email: krikrogh@rm.dk
-
Esbjerg, Denmark, 6700
- Recruiting
- Hospital of Southwest Jutland - Esbjerg
-
Contact:
- Peter Kuhne Qvist
- Phone Number: +45 7918 2000
- Email: Peter.Joachim.Kuhne-Qvist@rsyd.dk
-
Gødstrup, Denmark, 7400
- Recruiting
- Gødstrup Hospital
-
Contact:
- Peter Carøe Lind
- Phone Number: +45 7843 0000
- Email: pecali@clin.au.dk
-
Hjørring, Denmark, 9800
- Recruiting
- North Denmark Region Hospital - Hjørring
-
Contact:
- Cecilie Overgaard Nielsen
- Phone Number: +45 97 64 00 00
- Email: cenie@rn.dk
-
Horsens, Denmark, 8700
- Recruiting
- Horsens Regional Hospital
-
Contact:
- Lisa F Irion
- Phone Number: +45 7842 5000
- Email: LISIRI@rm.dk
-
Odense, Denmark, 5000
- Recruiting
- Odense University Hospital
-
Contact:
- Stine Thorhauge Zwisler
- Phone Number: +45 66 11 33 33
- Email: stine.zwisler@rsyd.dk
-
Contact:
- Nicole Brahe
- Phone Number: +45 66 11 33 33
- Email: nicole.brahe@rsyd.dk
-
Randers, Denmark, 8930
- Recruiting
- Randers Regional Hospital
-
Contact:
- Carsten Poulsen
- Phone Number: +45 78 42 00 00
- Email: carspoul@rm.dk
-
Viborg, Denmark, 8800
- Recruiting
- Viborg Regional Hospital
-
Contact:
- Hans K S Brødløs
- Phone Number: +45 78 44 00 00
- Email: Hans.Kristian.Sangill.Broedloes@Viborg.RM.dk
-
-
-
-
-
Trondheim, Norway, 7006
- Recruiting
- St. Olavs Hospital, Trondheim University Hospital
-
Contact:
- Eirik Skogvoll
- Phone Number: +4772573000
- Email: eirik.skogvoll@ntnu.no
-
Contact:
- Catrine Hem
- Phone Number: +4772573000
- Email: Catrine.Hem@stolav.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- In-hospital cardiac arrest
- Age ≥ 18 years
- >1minute of recorded ventilation data
Exclusion Criteria:
- Documented do-not-attempt cardiopulmonary resuscitation order
- Invasive mechanical circulatory support at the time of the cardiac arrest
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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). |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of patients with return of spontaneous circulation (ROSC)
Time Frame: ROSC is assessed immediately following cardiopulmonary resuscitation.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of patients surviving until day 30
Time Frame: Assessed at day 30 after cardiac arrest.
|
Patient survival for at least 30 days following cardiac arrest.
|
Assessed at day 30 after cardiac arrest.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fraction of patients with pulmonary complications
Time Frame: 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.
|
Composite endpoint of pulmonary complications after return of spontaneous circulation (ROSC) including acute respiratory distress syndrome (ARDS), aspiration, pneumothorax and hemothorax.
|
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
Time Frame: From date of ROSC until day 30 or date of death from any cause, whichever came first.
|
Days patients are alive without receiving mechanical ventilation after return of spontaneous circulation (ROSC).
|
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
Time Frame: From date of ROSC until day 90 or date of death from any cause, whichever came first.
|
Days patients are alive outside of the intensive care unit after return of spontaneous circulation (ROSC).
|
From date of ROSC until day 90 or date of death from any cause, whichever came first.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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;
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Pathological Conditions, Signs and Symptoms
- Respiratory Aspiration
- Heart Arrest
- Therapeutics
- Airway Management
- Resuscitation
- Emergency Treatment
- Respiratory Therapy
- Respiration, Artificial
- Noninvasive Ventilation
Other Study ID Numbers
- VENT-IHCA
- 1-16-02-301-24 (Registry Identifier: Internal Registry Central Denmark Region)
- 2022-0367531 (Registry Identifier: Internal Research Registry Aarhus University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Arrest
-
Fundacio d'Investigacio en Atencio Primaria Jordi...Hospital Universitari Joan XXIII de Tarragona.Enrolling by invitationCardiorespiratory Arrest | Cardiopulmonary Arrest with Successful ResuscitationSpain
-
TopLab Company for ART Laboratories Consultation...Benha UniversityUnknown
-
University Hospital, BrestCompleted
-
Medical University of ViennaCompletedCardiopulmonary Arrest With Successful Resuscitation | Cardiac Arrest | Cardiopulmonary Arrest | Cardiac Arrest, Out-Of-HospitalAustria
-
Lars Wiuff AndersenUniversity of AarhusRecruitingCardiac Arrest (CA)Denmark
-
National Taiwan University HospitalEnrolling by invitationOut of Hospital Cardiac Arrest | Inhospital Cardiac ArrestTaiwan
-
Haseki Training and Research HospitalCompletedCardiac Arrest (CA) | Out of Hospital Cardiac ArrestTurkey
-
KidSIM Simulation ProgramUniversity of Alabama at Birmingham; Columbia University; University of Southern... and other collaboratorsNot yet recruitingCardiac Arrest | Cardiopulmonary Arrest
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasCompletedCardiac Arrest | Cardiopulmonary ArrestUnited States
-
Dr. Steven BrooksUniversity of Manitoba; University of British Columbia; University of Toronto; Ohio... and other collaboratorsActive, not recruitingHeart Diseases | Cardiovascular Diseases | Heart Arrest | Out-Of-Hospital Cardiac ArrestUnited States, Canada
Clinical Trials on Positive pressure ventilation during cardiopulmonary resuscitation
-
Far Eastern Memorial HospitalCompletedOut-Of-Hospital Cardiac ArrestTaiwan
-
Azienda Ospedaliera di PadovaUnknownCardiopulmonary Bypass | Congenital Heart Disease | Mechanical Ventilation ComplicationItaly
-
Harran UniversityNot yet recruitingLumbar Disc Herniation | General Anesthesia | Prone Position | Spinal Surgery
-
Daping Hospital and the Research Institute of Surgery...Unknown
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedSleep Apnea, Obstructive | Fatigue | SarcoidosisItaly
-
University of PennsylvaniaUnited States Department of DefenseNot yet recruitingRespiratory Insufficiency | Amyotrophic Lateral Sclerosis (ALS) | Chronic Respiratory Failure | Neuromuscular Disease | Non-invasive Ventilation | Neuromuscular Disease Patients | Non-invasive Ventilatory Support | Respiratory Insufficiency Requiring Mechanical Ventilation | Positive Pressure Ventilation and other conditionsUnited States
-
Columbia UniversityTerminatedMotor Neuron Disease | Amyotrophic Lateral SclerosisUnited States
-
Krankenhaus Kloster GrafschaftUnknownChronic Respiratory FailureGermany
-
University of CreteCompletedObstructive Sleep Apnea | Idiopathic Pulmonary FibrosisGreece
-
University of CreteCompletedObstructive Sleep ApneaGreece