Cardiac Arrest and Ventilation Method

Not Applicable

Completed

• Conditions: Advanced Cardiac Life Support; Out-Of-Hospital Cardiac Arrest; Ventilation
• Interventions: Device: Manual Ventilation; Device: Automatic Mechanical Ventilation

• Registration Number: NCT05550454
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2021-12-13
• Study First Submitted: 2022-02-18
• Primary Completion: 2022-07-09
• Study Completion: 2022-07-31
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Ventilation	Manual Ventilation	Standard care with manual ventilation, Ambu-bagging, during ACLS
Automatic Mechanical Ventilation	Automatic Mechanical Ventilation	Automatic Mechanical Ventilation during ACLS

Primary Outcome Measures

Name	Time	Method
ROSC: return of spontaneous circulation	Within 20 minutes of ACLS	Rate of any ROSC after ACLS

Secondary Outcome Measures

Name	Time	Method
Arterial blood gas analysis (ABGA) parameters	The 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 parameters	During the entire ACLS time after randomization and endotracheal intubation	Tidal volume (TV) and Minute volume (MV) during the entire ACLS

Trial Locations

Locations (1)

Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea (the Republic Of), Korea, Republic of