Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy

NCT06718361 | Completed

• 1 other identifier: ZZSKVK-01-2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

oxygen; concentration of oxygen; risk of fire; airway management

Outcome Measures

Primary Outcomes (1)

• Oxygen levels

  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 Outcomes (1)

• Normal oxygen levels 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.

Study Arms (5)

O2 mask

Delivering oxygen via face mask with different oxygen flow (5, 10, 15 l/min).

Other: Oxygen levels measurement (%)

Bag mask ventilation

Delivering oxygen via bag mask ventilation

Other: Oxygen levels measurement (%)

Supraglotic airway

Delivering oxygen via laryngeal mask with bag or mechanical ventilation

Other: Oxygen levels measurement (%)

Orotracheal intubation

Delivering oxygen via orotracheal tube with bag or mechanical ventilation

Other: Oxygen levels measurement (%)

High-Flow Nasal Oxygenation

Oxygen delivery via high-flow nasal oxygenation

Other: Oxygen levels measurement (%)

Interventions

Oxygen levels measurement (%) OTHER

Measuring levels of oxygen in the environment around the patient in %.

Bag mask ventilation; High-Flow Nasal Oxygenation; O2 mask; Orotracheal intubation; Supraglotic airway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients undergoing oxygen therapy.

You may qualify if:

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

You may not qualify if:

• no oxygen therapy started
• situation not allowing measurement

Sponsors & Collaborators

• David Peran, PhD, FERC: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

FNKV University Hospital

Prague, 100 34, Czechia

Location

Related Publications (6)

• 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.

  PMID: 9771170 BACKGROUND

• Theodorou 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.

  PMID: 12949302 BACKGROUND

• Miller PH. Potential fire hazard in defibrillation. JAMA. 1972 Jul 10;221(2):192. No abstract available.

  PMID: 5067634 BACKGROUND

• Cantello 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.

  PMID: 9681318 BACKGROUND

• Barker 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.

  PMID: 11574364 BACKGROUND

• Hummel 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.

  PMID: 3184368 BACKGROUND

Study Officials

• David Peran, PhD

  Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: February 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)