Trial Outcomes & Findings for Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation. (NCT NCT03766646)

NCT ID: NCT03766646

Last Updated: 2020-10-30

Results Overview

Oxygen fraction in first expired breath post preoxygenation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: At the end of 3 minutes preoxygenation
• Results posted on: 2020-10-30

Participant Flow

Participant milestones

Measure	Speech Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen	Non-speech Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen
Overall Study STARTED	19	15
Overall Study COMPLETED	18	12
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Speech Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen	Non-speech Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	3

Baseline Characteristics

Participants not suitable for analysis

Baseline characteristics by cohort

Measure	Speech n=19 Participants Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen	Non-speech n=15 Participants Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants • Participants not suitable for analysis	0 Participants n=12 Participants • Participants not suitable for analysis	0 Participants n=30 Participants • Participants not suitable for analysis
Age, Categorical Between 18 and 65 years	18 Participants n=18 Participants • Participants not suitable for analysis	12 Participants n=12 Participants • Participants not suitable for analysis	30 Participants n=30 Participants • Participants not suitable for analysis
Age, Categorical >=65 years	0 Participants n=18 Participants • Participants not suitable for analysis	0 Participants n=12 Participants • Participants not suitable for analysis	0 Participants n=30 Participants • Participants not suitable for analysis
Sex: Female, Male Female	18 Participants n=18 Participants • Participant withdrawal/ unsuitable for analysis	12 Participants n=12 Participants • Participant withdrawal/ unsuitable for analysis	30 Participants n=30 Participants • Participant withdrawal/ unsuitable for analysis
Sex: Female, Male Male	0 Participants n=18 Participants • Participant withdrawal/ unsuitable for analysis	0 Participants n=12 Participants • Participant withdrawal/ unsuitable for analysis	0 Participants n=30 Participants • Participant withdrawal/ unsuitable for analysis
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	27.0 kg.m-2 n=19 Participants	26.5 kg.m-2 n=15 Participants	26.7 kg.m-2 n=34 Participants

PRIMARY outcome

Timeframe: At the end of 3 minutes preoxygenation

Oxygen fraction in first expired breath post preoxygenation

Outcome measures

Measure	Speech n=18 Participants Participants were asked to read a standardised script aloud for 3 minutes whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen	Non-speech n=12 Participants Participants were asked to breathe in and out of their nose for 3 minutes, with a closed mouth, whilst receiving oxygen from the Optiflow device. At the end of 3 minutes End Tidal Oxygen was measured and recorded. Optiflow: 45l.min oxygen
End Tidal Oxygen Fraction	43.9 percentage of End-Tidal Oxygen Fraction Standard Deviation 15.4	81.9 percentage of End-Tidal Oxygen Fraction Standard Deviation 8.3

Adverse Events

Speech

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-speech

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Patrick Butler

University Hospital Southampton

Phone: 81205662

Email: patrick.butler@uhs.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place