Cardiac Arrest and Ventilation Method

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-13

Study Completion Date

2022-07-31

Brief Summary

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Comparison of Manual Ventilation and Automatic Mechanical Ventilation during CPR, Pilot \& Feasibility Study (CAVE-I trial)

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Automatic Mechanical Ventilation

Automatic Mechanical Ventilation during ACLS

Group Type EXPERIMENTAL

Automatic Mechanical Ventilation

Intervention Type DEVICE

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 Ventilation

Standard care with manual ventilation, Ambu-bagging, during ACLS

Group Type ACTIVE_COMPARATOR

Manual Ventilation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Manual Ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No