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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speech | Experimental | 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. |
|
| Non-speech | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optiflow | Device | 45l.min oxygen |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| End Tidal Oxygen Fraction | Oxygen fraction in first expired breath post preoxygenation | At the end of 3 minutes preoxygenation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Butler | Unvistery Hospital Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Southampton | Southampton | Hants | SO16 6YD | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Non-speech |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participants not suitable for analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | End Tidal Oxygen Fraction | Oxygen fraction in first expired breath post preoxygenation | Posted | Mean | Standard Deviation | percentage of End-Tidal Oxygen Fraction | At the end of 3 minutes preoxygenation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Patrick Butler | University Hospital Southampton | 81205662 | +44 (0)23 | patrick.butler@uhs.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2018 | Nov 30, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2019 | Sep 17, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013060 | Speech |
| ID | Term |
|---|---|
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
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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
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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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Participant withdrawal/ unsuitable for analysis | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Median | Full Range | kg.m-2 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 | 0 | 0 |
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