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

January 13, 2025 updated by: University Hospital, Ghent
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 minutes
Measured ventilation frequency (with or without ventilation feedback)
2 minutes
Delivered ventilation volume
Time Frame: 2 minutes
Measured ventilation volume (with or without ventilation feedback)
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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