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NCT05550454 Clinical Trial

Cardiac Arrest and Ventilation Method

Out-Of-Hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05550454
Other study ID # CAVE-I(P)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2021
Est. completion date July 31, 2022

Study information
Verified date April 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 31, 2022
Est. primary completion date July 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center Seoul Korea (the Republic Of)

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other 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
Primary ROSC: return of spontaneous circulation Rate of any ROSC after ACLS Within 20 minutes of ACLS
Secondary 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.
Secondary Ventilation parameters Tidal volume (TV) and Minute volume (MV) during the entire ACLS During the entire ACLS time after randomization and endotracheal intubation
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