Clinical trial NCT06718361: Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy
Official title: Assessing Environmental Oxygen Levels During Artificial Ventilation and Oxygen Therapy: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Delivery
Intubation
Airway Control
Concentration
Keywords: oxygen
concentration of oxygen
risk of fire
airway management
Lead sponsor: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
First posted: 2024-12-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients undergoing oxygen therapy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oxygen levels
timeFrame: 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:
measure: Normal oxygen levels after the end of oxygen therapy
timeFrame: 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.
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: FNKV University Hospital
Study officials:
affiliation: Zdravotnicka Zachranna Sluzba Karlovarskeho Kraje, P.O.
name: David Peran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Miller PH. Potential fire hazard in defibrillation. JAMA. 1972 Jul 10;221(2):192. No abstract available.
citation: 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.
citation: 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.
citation: 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.