Out-Of-Hospital Cardiac ArrestNCT05550454
Cardiac Arrest and Ventilation Method
A study testing Automatic Mechanical Ventilation and Manual Ventilation in people with Out-Of-Hospital Cardiac Arrest and Advanced Cardiac Life Support, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation
- What is being tested?
- Automatic Mechanical Ventilation and Manual Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest (OHCA)
- Transferred by only EMS without prehospital return of spontaneous circulation (ROSC)
- ACLS for at least 20 minutes in the emergency room
- Arterial blood gas analysis at least once during ACLS
Who cannot join
- In-hospital cardiac arrest (IHCA)
- Not transferred by Emergency Medical Service
- ROSC gained before arriving at the ER
- OHCA caused by trauma
- ACLS is not performed for more than 20 minutes because the death is obvious
- Not able to intubate the trachea
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center
Seoul, Korea (the Republic Of), 07061
About this study
Official title: Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial)
Read the detailed description
This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.
- Being tested
- Automatic Mechanical Ventilation, Manual Ventilation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Mechanical VentilationDevice
Ventilation settings:
Mode: (S)Continuous Mandatory Ventilation Rate: 10 b/min. Tidal Volume: 500 ml (male), 450 ml (female) I:E=1:1 Positive end expiratory pressure (PEEP): 5 cmH2O Flow trigger: off Oxygen: 100% Alarms: Pressure 70 cmH20, Tidal volume 100 ~ 1,000 ml
Manual VentilationDevice
Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel
| Study group | Role | What they receive |
|---|---|---|
| Automatic Mechanical Ventilation | Experimental | Automatic Mechanical Ventilation during ACLS Receives: Device: Automatic Mechanical Ventilation |
| Manual Ventilation | Active comparator | Standard care with manual ventilation, Ambu-bagging, during ACLS Receives: Device: Manual Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROSC: return of spontaneous circulation
Rate of any ROSC after ACLS
Measured: Within 20 minutes of ACLS
Secondary outcomes (2)
Arterial blood gas analysis (ABGA) parameters
PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L
Measured: The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.
Ventilation parameters
Tidal volume (TV) and Minute volume (MV) during the entire ACLS
Measured: During the entire ACLS time after randomization and endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start13 Dec 2021
- Primary completion9 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550454
- Sponsor's protocol ID
- CAVE-I(P)
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin J, Lee HJ, Jin KN, Shin JH, You KM, Lee SGW, Jung JH, Song KJ, Pak J, Park TY, Park CJ, Bae GT. Automatic Mechanical Ventilation vs Manual Bag Ventilation During CPR: A Pilot Randomized Controlled Trial. Chest. 2024 Aug;166(2):311-320. doi: 10.1016/j.chest.2024.02.020. Epub 2024 Feb 18.
PubMed 38373673
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
- ClinicalTrials.gov ID
- NCT05550454
- Acronym / sponsor ID
- CAVE-I(P)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 9 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial)
Detailed description
This is a preliminary randomized clinical trials comparing the effectiveness of the automatic mechanical ventilation method compared to manual ventilation methods commonly performed during advanced cardiac life support (ACLS) in emergency room for out-of-hospital cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
| Arm | Type | Receives |
|---|---|---|
| Automatic Mechanical Ventilation | Experimental | Device: Automatic Mechanical VentilationAutomatic Mechanical Ventilation during ACLS |
| Manual Ventilation | Active comparator | Device: Manual VentilationStandard care with manual ventilation, Ambu-bagging, during ACLS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Out-of-hospital cardiac arrest (OHCA)
- Transferred by only EMS without prehospital return of spontaneous circulation (ROSC)
- ACLS for at least 20 minutes in the emergency room
- Arterial blood gas analysis at least once during ACLS
Key exclusion criteria (6 listed)
- In-hospital cardiac arrest (IHCA)
- Not transferred by Emergency Medical Service
- ROSC gained before arriving at the ER
- OHCA caused by trauma
- ACLS is not performed for more than 20 minutes because the death is obvious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Mechanical VentilationVentilation settings: Mode: (S)Continuous Mandatory Ventilation Rate: 10 b/min. Tidal Volume: 500 ml (male), 450 ml (female) I:E=1:1 Positive end expiratory pressure (PEEP): 5 cmH2O Flow trigger: off Oxygen: 100% Alarms: Pressure 70 cmH20, Tidal volume 100 ~ 1,000 ml | Device | Automatic Mechanical Ventilation |
| Manual VentilationAmbu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel | Device | Manual Ventilation |
Primary outcome
ROSC: return of spontaneous circulation
Time frame: Within 20 minutes of ACLS
Rate of any ROSC after ACLS
2 secondary outcomes
Arterial blood gas analysis (ABGA) parameters
Time frame: The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.
Ventilation parameters
Time frame: During the entire ACLS time after randomization and endotracheal intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 38373673Shin J, Lee HJ, Jin KN, Shin JH, You KM, Lee SGW, Jung JH, Song KJ, Pak J, Park TY, Park CJ, Bae GT. Automatic Mechanical Ventilation vs Manual Bag Ventilation During CPR: A Pilot Randomized Controlled Trial. Chest. 2024 Aug;166(2):311-320. doi: 10.1016/j.chest.2024.02.020. Epub 2024 Feb 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Mechanical Ventilation and Manual Ventilation in people with Out-Of-Hospital Cardiac Arrest and Advanced Cardiac Life Support, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROSC: return of spontaneous circulation (time frame: Within 20 minutes of ACLS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.