Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy

May 13, 2025 updated by: David Peran, PhD, FERC

Assessing Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy: Prospective Observational Study

European Resuscitation Council 2021 Guidelines and Advanced Life Support Provider Courses teach that the oxygen supply must be removed from the patient during defibrillation to the distance of minimum of 1 meter. Scientific articles describe few incidents of fire during defibrillation in oxygen - enriched atmospheres.

The study aims to performed a series of measurement of the oxygen concentration in the environment around the patient with different airway management used and ventilation provided.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • Czechia
      • Prague, Czechia, 100 34
        • FNKV University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients undergoing oxygen therapy.

Description

Inclusion Criteria:

  • patients at the intensive care unit bed or on the operating theatre with oxygen therapy prescribed/indicated

Exclusion Criteria:

  • no oxygen therapy started
  • situation not allowing measurement

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
O2 mask
Delivering oxygen via face mask with different oxygen flow (5, 10, 15 l/min).
Other: Oxygen levels measurement (%)
Measuring levels of oxygen in the environment around the patient in %.
Bag mask ventilation
Delivering oxygen via bag mask ventilation
Other: Oxygen levels measurement (%)
Measuring levels of oxygen in the environment around the patient in %.
Supraglotic airway
Delivering oxygen via laryngeal mask with bag or mechanical ventilation
Other: Oxygen levels measurement (%)
Measuring levels of oxygen in the environment around the patient in %.
Orotracheal intubation
Delivering oxygen via orotracheal tube with bag or mechanical ventilation
Other: Oxygen levels measurement (%)
Measuring levels of oxygen in the environment around the patient in %.
High-Flow Nasal Oxygenation
Oxygen delivery via high-flow nasal oxygenation
Other: Oxygen levels measurement (%)
Measuring levels of oxygen in the environment around the patient in %.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen levels
Time Frame: From the initiation of oxygen therapy at the start of anesthesia induction until the completion of oxygen therapy at the end of the procedure (ranging from 30 minutes to 6 hours), oxygen concentration will be assessed continuously.
The oxygen levels in percentage
From the initiation of oxygen therapy at the start of anesthesia induction until the completion of oxygen therapy at the end of the procedure (ranging from 30 minutes to 6 hours), oxygen concentration will be assessed continuously.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normal oxygen levels after the end of oxygen therapy
Time Frame: From the end of oxygen therapy at the completion of procedure until the reappearance of normal oxygen levels (21%), assessed continuously, up to 10 minutes.
Time till the normal level of oxygen is reached after the end of oxygen therapy
From the end of oxygen therapy at the completion of procedure until the reappearance of normal oxygen levels (21%), assessed continuously, up to 10 minutes.

Collaborators and Investigators

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

Sponsor

David Peran, PhD, FERC

Collaborators

Charles University, Czech Republic

Investigators

  • Principal Investigator: David Peran, PhD, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2025

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ZZSKVK-01-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data will be part of the future publication.

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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