Skip to content

Cardiac Arrest and Ventilation Method

Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05550454
Enrollment
60
Registered
2022-09-22
Start date
2021-12-13
Completion date
2022-07-31
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation

Brief summary

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.

Interventions

DEVICEAutomatic Mechanical Ventilation

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

Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
ROSC: return of spontaneous circulationWithin 20 minutes of ACLSRate of any ROSC after ACLS

Secondary

MeasureTime frameDescription
Arterial blood gas analysis (ABGA) parametersThe first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L
Ventilation parametersDuring the entire ACLS time after randomization and endotracheal intubationTidal volume (TV) and Minute volume (MV) during the entire ACLS

Other

MeasureTime frameDescription
Peak pressure (only in automatic mechanical ventilation group)Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubationPeak pressure of ventilator during the entire ACLS

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026