Cardiac Arrest and Ventilation Method

NCT05550454 | Completed

• 1 other identifier: CAVE-I(P)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ROSC: return of spontaneous circulation

  Rate of any ROSC after ACLS

  Within 20 minutes of ACLS

Secondary Outcomes (2)

• 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.

• Ventilation parameters

  During the entire ACLS time after randomization and endotracheal intubation

Other Outcomes (1)

• Peak pressure (only in automatic mechanical ventilation group)

  Randomized by automatic mechanical ventilation and during the entire ACLS time after endotracheal intubation

Study Arms (2)

Automatic Mechanical Ventilation

EXPERIMENTAL

Automatic Mechanical Ventilation during ACLS

Device: Automatic Mechanical Ventilation

Manual Ventilation

ACTIVE COMPARATOR

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

Device: Manual Ventilation

Interventions

Automatic Mechanical Ventilation 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

Automatic Mechanical Ventilation

Manual Ventilation DEVICE

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

Manual Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center

Seoul, Korea (the Republic Of), 07061, South Korea

Location

Related Publications (1)

• Shin J, Lee HJ, Jin KN, Shin JH, You KM, Lee SGW, Jung JH, Song KJ, Pak J, Park TY, Park CJ, Bae GT. Automatic Mechanical Ventilation vs Manual Bag Ventilation During CPR: A Pilot Randomized Controlled Trial. Chest. 2024 Aug;166(2):311-320. doi: 10.1016/j.chest.2024.02.020. Epub 2024 Feb 18.

  PMID: 38373673 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: September 22, 2022
• Study Start: December 13, 2021
• Primary Completion: July 9, 2022
• Study Completion: July 31, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

KR (1)