Cardiac Arrest and Ventilation Method

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)

Study Overview

• Status: Completed
• Conditions: Ventilation; Out-Of-Hospital Cardiac Arrest; Advanced Cardiac Life Support
• Intervention / Treatment: Device: Automatic Mechanical Ventilation; Device: Manual Ventilation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea (the Republic Of)
    • Seoul, Korea (the Republic Of), Korea, Republic of, 07061
      • Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic Mechanical Ventilation; Automatic Mechanical Ventilation during ACLS	Device: Automatic 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
Active Comparator: Manual Ventilation; Standard care with manual ventilation, Ambu-bagging, during ACLS	Device: Manual Ventilation; Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROSC: return of spontaneous circulation	Rate of any ROSC after ACLS	Within 20 minutes of ACLS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood gas analysis (ABGA) parameters	PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L	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	During the entire ACLS time after randomization and endotracheal intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak pressure (only in automatic mechanical ventilation group)	Peak pressure of ventilator during the entire ACLS	Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): July 9, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: CAVE-I(P)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No