Unrecognized Condition
Conditions
Keywords
Optiflow, High Flow Nasal Oxygen, Preoxygenation, Speech
Brief summary
If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?
Detailed description
This is a randomised controlled trial on 34 patients undergoing routine elective surgery at the Princess Anne Hospital, Southampton. The study will take place from September 2018 to January 2019 and involve preoxygenating all participants for three minutes using the Optiflow™ device. During this time, participants will be instructed to either read aloud a standardised text or to breathe through their nose with a closed mouth. At the end of 3 minutes, the primary outcome, ETO2, will be measured and recorded.
Interventions
DEVICEOptiflow
45l.min oxygen
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
After recruitment, patients were randomised into one of two arms, speech or non-speech. Both the investigator and the participant were aware of the intervention assigned
Intervention model description
Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18-35, ASA category 1 or 2
Exclusion criteria
* Inability to read/ follow instructions, Heavily sedated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End Tidal Oxygen Fraction | At the end of 3 minutes preoxygenation | Oxygen fraction in first expired breath post preoxygenation |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 15 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Speech | Non-speech | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 12 Participants | 30 Participants |
| BMI | 27.0 kg.m-2 | 26.5 kg.m-2 | 26.7 kg.m-2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 12 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
End Tidal Oxygen Fraction
Oxygen fraction in first expired breath post preoxygenation
Time frame: At the end of 3 minutes preoxygenation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Speech | End Tidal Oxygen Fraction | 43.9 percentage of End-Tidal Oxygen Fraction | Standard Deviation 15.4 |
| Non-speech | End Tidal Oxygen Fraction | 81.9 percentage of End-Tidal Oxygen Fraction | Standard Deviation 8.3 |