Oxygen DeliveryNCT06718361
Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy
An observational study of Oxygen Delivery and Intubation, run by David Peran, PhD, FERC at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oxygen Delivery, Intubation, Airway Control
- What is being tested?
- Oxygen levels measurement (%)
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients undergoing oxygen therapy.
Who may be able to join
- patients at the intensive care unit bed or on the operating theatre with oxygen therapy prescribed/indicated
Who cannot join
- no oxygen therapy started
- situation not allowing measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Oxygen Delivery, Intubation, Airway Control, Concentration
- Being tested
- Oxygen levels measurement (%)
- Keywords
- oxygen, concentration of oxygen, risk of fire, airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen levels measurement (%)Other
Measuring levels of oxygen in the environment around the patient in %.
| Study group | Role | What they receive |
|---|---|---|
| O2 mask | Delivering oxygen via face mask with different oxygen flow (5, 10, 15 l/min). Receives: Other: Oxygen levels measurement (%) | |
| Bag mask ventilation | Delivering oxygen via bag mask ventilation Receives: Other: Oxygen levels measurement (%) | |
| Supraglotic airway | Delivering oxygen via laryngeal mask with bag or mechanical ventilation Receives: Other: Oxygen levels measurement (%) | |
| Orotracheal intubation | Delivering oxygen via orotracheal tube with bag or mechanical ventilation Receives: Other: Oxygen levels measurement (%) | |
| High-Flow Nasal Oxygenation | Oxygen delivery via high-flow nasal oxygenation Receives: Other: Oxygen levels measurement (%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen levels
The oxygen levels in percentage
Measured: 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 outcomes (1)
Normal oxygen levels after the end of oxygen therapy
Time till the normal level of oxygen is reached after the end of oxygen therapy
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Peran, PhD, FERC
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Sponsor-investigator, David Peran, PhD, FERC, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
- Investigators
- David Peran, PhD, Principal investigator, Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718361
- Sponsor's protocol ID
- ZZSKVK-01-2024
- Status last verified
- May 2025
- First submitted
- 26 Nov 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be part of the future publication.
Publications
Robertshaw H, McAnulty G. Ambient oxygen concentrations during simulated cardiopulmonary resuscitation. Anaesthesia. 1998 Jul;53(7):634-7. doi: 10.1046/j.1365-2044.1998.410-az0512.x.
PubMed 9771170Theodorou AA, Gutierrez JA, Berg RA. Fire attributable to a defibrillation attempt in a neonate. Pediatrics. 2003 Sep;112(3 Pt 1):677-9. doi: 10.1542/peds.112.3.677. No abstract available.
PubMed 12949302Miller PH. Potential fire hazard in defibrillation. JAMA. 1972 Jul 10;221(2):192. No abstract available.
PubMed 5067634Cantello E, Davy TE, Koenig KL. The question of removing a ventilation bag before defibrillation. J Accid Emerg Med. 1998 Jul;15(4):286. doi: 10.1136/emj.15.4.286. No abstract available.
PubMed 9681318Barker SJ, Polson JS. Fire in the operating room: a case report and laboratory study. Anesth Analg. 2001 Oct;93(4):960-5. doi: 10.1097/00000539-200110000-00031.
PubMed 11574364Hummel RS 3rd, Ornato JP, Weinberg SM, Clarke AM. Spark-generating properties of electrode gels used during defibrillation. A potential fire hazard. JAMA. 1988 Nov 25;260(20):3021-4.
PubMed 3184368
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06718361
- Acronym / sponsor ID
- ZZSKVK-01-2024
- Conditions
- Oxygen Delivery, Intubation, Airway Control, Concentration
- Keywords
- oxygen, concentration of oxygen, risk of fire, airway management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- David Peran, PhD, FERCUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| O2 mask | – | Other: Oxygen levels measurement (%)Delivering oxygen via face mask with different oxygen flow (5, 10, 15 l/min). |
| Bag mask ventilation | – | Other: Oxygen levels measurement (%)Delivering oxygen via bag mask ventilation |
| Supraglotic airway | – | Other: Oxygen levels measurement (%)Delivering oxygen via laryngeal mask with bag or mechanical ventilation |
| Orotracheal intubation | – | Other: Oxygen levels measurement (%)Delivering oxygen via orotracheal tube with bag or mechanical ventilation |
| High-Flow Nasal Oxygenation | – | Other: Oxygen levels measurement (%)Oxygen delivery via high-flow nasal oxygenation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients undergoing oxygen therapy.
Key inclusion criteria (1 listed)
- patients at the intensive care unit bed or on the operating theatre with oxygen therapy prescribed/indicated
Key exclusion criteria (2 listed)
- no oxygen therapy started
- situation not allowing measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen levels measurement (%)Measuring levels of oxygen in the environment around the patient in %. | Other | Bag mask ventilation, High-Flow Nasal Oxygenation, O2 mask, Orotracheal intubation, Supraglotic airway |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 9771170Robertshaw H, McAnulty G. Ambient oxygen concentrations during simulated cardiopulmonary resuscitation. Anaesthesia. 1998 Jul;53(7):634-7. doi: 10.1046/j.1365-2044.1998.410-az0512.x.
- Background: PubMed 12949302Theodorou AA, Gutierrez JA, Berg RA. Fire attributable to a defibrillation attempt in a neonate. Pediatrics. 2003 Sep;112(3 Pt 1):677-9. doi: 10.1542/peds.112.3.677. No abstract available.
- Background: PubMed 5067634Miller PH. Potential fire hazard in defibrillation. JAMA. 1972 Jul 10;221(2):192. No abstract available.
- Background: PubMed 9681318Cantello E, Davy TE, Koenig KL. The question of removing a ventilation bag before defibrillation. J Accid Emerg Med. 1998 Jul;15(4):286. doi: 10.1136/emj.15.4.286. No abstract available.
- Background: PubMed 11574364Barker SJ, Polson JS. Fire in the operating room: a case report and laboratory study. Anesth Analg. 2001 Oct;93(4):960-5. doi: 10.1097/00000539-200110000-00031.
- Background: PubMed 3184368Hummel RS 3rd, Ornato JP, Weinberg SM, Clarke AM. Spark-generating properties of electrode gels used during defibrillation. A potential fire hazard. JAMA. 1988 Nov 25;260(20):3021-4.
- Individual participant dataSharing planned: No. All data will be part of the future publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Peran, PhD principal investigator
Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Delivery and Intubation, run by David Peran, PhD, FERC at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06718361, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.