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Cardiac Arrest and Ventilation Method

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Automatic Mechanical Ventilation
Manual Ventilation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Automatic Mechanical Ventilation

Manual Ventilation

Arm Description

Automatic Mechanical Ventilation during ACLS

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

Outcomes

Primary Outcome Measures

ROSC: return of spontaneous circulation
Rate of any ROSC after ACLS

Secondary Outcome Measures

Arterial blood gas analysis (ABGA) parameters
PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L
Ventilation parameters
Tidal volume (TV) and Minute volume (MV) during the entire ACLS

Full Information

First Posted
February 18, 2022
Last Updated
April 4, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05550454
Brief Title
Cardiac Arrest and Ventilation Method
Official Title
Comparison of Manual Ventilation and Automatic Mechanical Ventilation During Cardiopulmonary Resuscitation, Pilot & Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
July 9, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Advanced Cardiac Life Support, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a study conducted by random assignment to two groups of manual ventilation and automatic mechanical ventilation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic Mechanical Ventilation
Arm Type
Experimental
Arm Description
Automatic Mechanical Ventilation during ACLS
Arm Title
Manual Ventilation
Arm Type
Active Comparator
Arm Description
Standard care with manual ventilation, Ambu-bagging, during ACLS
Intervention Type
Device
Intervention Name(s)
Automatic Mechanical Ventilation
Intervention Description
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
Intervention Name(s)
Manual Ventilation
Intervention Description
Ambu-bagging (It is recommended in the guidelines as a ventilation method.) Methods: 10 times per minutes by medical personnel
Primary Outcome Measure Information:
Title
ROSC: return of spontaneous circulation
Description
Rate of any ROSC after ACLS
Time Frame
Within 20 minutes of ACLS
Secondary Outcome Measure Information:
Title
Arterial blood gas analysis (ABGA) parameters
Description
PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L
Time Frame
The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.
Title
Ventilation parameters
Description
Tidal volume (TV) and Minute volume (MV) during the entire ACLS
Time Frame
During the entire ACLS time after randomization and endotracheal intubation
Other Pre-specified Outcome Measures:
Title
Peak pressure (only in automatic mechanical ventilation group)
Description
Peak pressure of ventilator during the entire ACLS
Time Frame
Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center
City
Seoul
State/Province
Korea (the Republic Of)
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

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Cardiac Arrest and Ventilation Method

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