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A pilot study comparing oxygen delivery from 4 different delivery devices under hyperbaric conditions on healthy volunteers.

A pilot study comparing oxygen delivery from 4 different delivery devices under hyperbaric conditions on healthy volunteers.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001545752
Enrollment
6
Registered
2022-12-13
Start date
2020-09-01
Completion date
2022-04-30
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

ABSTRACT BACKGROUND - Hyperbaric oxygen therapy is used for a range of emergent conditions such as decompression illness and chronic conditions such as soft tissue radiation injury. In multiplace chambers oxygen is delivered to patients different methods including a ventilated hood system, a demand valve system with an oronasal mask, and an endotracheal tube. The choice of oxygen delivery system is a balance of clinical situation, patient factors and resources of the chamber. AIMS - The primary aim of this study was to compare the concentration of oxygen delivered via different delivery devices available at our institution under pressurized conditions. The secondary aim was to assess the breathability and perceived comfort of a ventilated hood system and oronasal masks.

Interventions

The devices used were: • “Hans Rudolph” Rudolph Nasal & Mouth Breathing Mask Face mask with head straps (model number 8930, Hans Rudolph, Kansas, U.S.A) • “Scott” Pressur VakTM II Face Mask (model number 803600, Amron Vista, California) • “Hsiner” CPAP/VPAP silicone medium face mask with head straps (Model number 10214, HSINER, Taichung City, Taiwan) • “Oxygen Hood” Amron Oxygen Treatment Hood. (Model number 8891, Amron, Vista, California) 100% oxygen was used. The oxygen used was not warme

The devices used were: • “Hans Rudolph” Rudolph Nasal & Mouth Breathing Mask Face mask with head straps (model number 8930, Hans Rudolph, Kansas, U.S.A) • “Scott” Pressur VakTM II Face Mask (model number 803600, Amron Vista, California) • “Hsiner” CPAP/VPAP silicone medium face mask with head straps (Model number 10214, HSINER, Taichung City, Taiwan) • “Oxygen Hood” Amron Oxygen Treatment Hood. (Model number 8891, Amron, Vista, California) 100% oxygen was used. The oxygen used was not warmed or humidified Head straps were used to secure the Hsiner and Hans Rudolph masks onto the subject’s face. The neck seal for the hood was placed around the subject’s neck outside the chamber before pressurization and the hood was secured and inflated by the subject on testing. The Scott mask was held onto the face by the subject and the subject was asked to ensure a tight seal to avoid leakage. The Scott mask was held in place without head straps to replicate the clinical practice at our institution. A high-pressure O2 hose connects the demand valve to the oxygen O2 outlet. A high-efficiency particulate air (HEPA) filter was attached between the demand valve and mask. To measure the intra-mask oxygen levels, a size 6 paediatric nasogastric (NG) tube was placed through a hole drilled into the side of the mask to lie in the mask dead space. For the oxygen hood, an NG tube was positioned underneath the neck seal on the right side of the subject’s face. The NG tube was connected to a sampling line leading outside the chamber. Mask O2 analysis was performed by connecting the sampling line to a Datex Ohmeda D-CU8 with a MiniTPX side stream gas analyser. The devices were placed on the head by the participants. The overall duration of observation was 50 mins All participants were exposed to all the different devices. There was no washout period.

Sponsors

Kenneth Lo
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

The volunteers for this study were healthy non-smoking technicians and doctors of both sexes

Exclusion criteria

any patients any emergency treatment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026