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Completed

NCT Number: NCT05550454

Cardiac Arrest and Ventilation Method

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

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Advanced Cardiac Life Support Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Goverment-Seoul National University Boramae Medical Center

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Manual Ventilation

Device

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

Primary outcomes

  1. ROSC: return of spontaneous circulation

    Time frame: Within 20 minutes of ACLS

    Rate of any ROSC after ACLS

Secondary outcomes

  1. Arterial blood gas analysis (ABGA) parameters

    Time frame: The first test was conducted within 5 minutes of ACLS, and the second test 10 minutes after the first test.

    PH (no unit), PO2 in mmHg, PCO2 in mmHg, HCO3 in mEq/L

  2. Ventilation parameters

    Time frame: During the entire ACLS time after randomization and endotracheal intubation

    Tidal volume (TV) and Minute volume (MV) during the entire ACLS

Other outcomes

  1. Peak pressure (only in automatic mechanical ventilation group)

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

    Peak pressure of ventilator during the entire ACLS

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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