The Impact of Real Time Ventilation Feedback on Ventilation Rate and Tidal Volume During Cardiac Arrest.

During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: Ventilation feedback device

Detailed Description

During cardiac arrest, patients are intubated, ventilation is performed using a manual resuscitator. Hereafeter, a flowsensor is connected. During the first cycle, patients are ventilated without any feedback (whilst the sensor is recording the delivered ventilation). During the second cycle, realtime delivered flow is shown on the screen, informing the user on the delivered ventilation volume and ventilation rate. Data is saved automatically after use.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxim Vanwulpen, MD; Phone Number: 09 332 21 11; Email: maxim.vanwulpen@uzgent.be
• Study Contact Backup: Name: Said Hachimi-Idrissi, MD; Phone Number: 09 332 21 11

Study Locations

• Belgium
  • Ghent, Belgium
    • Recruiting
    • Ghent University Hospital
    • Contact: Said Hachimi-Idrissi, MD
  • West-Vlaanderen
    • Knokke, West-Vlaanderen, Belgium, 8301
      • Not yet recruiting
      • AZ Zeno
      • Contact: Maxim Vanwulpen, MD; Phone Number: 3250 535 112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-

Exclusion Criteria:

Traumatic cardiac arrest Inability to intubate patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventilation feedback; First, ventilation without feedback, hereafter ventilation with feedback	Device: Ventilation feedback device; Device showing delivered ventilation frequency and volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivered ventilation frequency	Measured ventilation frequency (with or without ventilation feedback)	2 minutes
Delivered ventilation volume	Measured ventilation volume (with or without ventilation feedback)	2 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest
• Other Study ID Numbers: ONZ-2023-0613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No