Comparison of an ordinary mask and an open face mask

Comparison of an ordinary mask and an open face mask - The open face mask study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023371

Enrollment

Registered

2016-07-29

Start date

2016-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

respiratory failure

Interventions

We applied both masks (ordinary and open face mask) with various flow rates: 5, 4, 3, 2, 1 and 0.5 l/min for three minutes, respectively. First, we tried ordinary masks with 5 l/min for 15 minutes and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stable ICU patients who suffered from mild respiratory failure

Exclusion criteria

Exclusion criteria: The patients who are not arousal. The patients who are unstable. The patients who need positive pressure ventilation to maintain their SpO2.

Design outcomes

Primary

Measure	Time frame
Fraction of inspired carbon dioxide (FICO2) after 15 minutes of 5L/min oxygen, and with variable flows(4,3,2,1 and 0.5L/min: the flow is decreased every 3 minutes) by using an open face mask and an ordinary mask.	—

Secondary

Measure	Time frame
Respiratory rate, end-tidal CO2, SpO2 and patients' satisfaction with the mask, under the same conditions.	—

Countries

Japan

Contacts

Public ContactTadahiro Kobayashi

Yamagata University Faculty of Medicine Department of Emergency and Critical Care Medicine

tad.kob11@gmail.com023-628-5400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026