Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.

NCT03766646 | Completed Results

• 1 other identifier: RHM CR10369
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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?

Conditions

Unrecognized Condition

Keywords

Optiflow; High Flow Nasal Oxygen; Preoxygenation; Speech

Outcome Measures

Primary Outcomes (1)

• End Tidal Oxygen Fraction

  Oxygen fraction in first expired breath post preoxygenation

  At the end of 3 minutes preoxygenation

Study Arms (2)

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.

Device: Optiflow

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.

Device: Optiflow

Interventions

Optiflow DEVICE

45l.min oxygen

Also known as: HFNO, High Flow Nasal Oxygen

Non-speech; Speech

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 18-35, ASA category 1 or 2

You may not qualify if:

• Inability to read/ follow instructions, Heavily sedated

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton

Southampton, Hants, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Speech

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior

Results Point of Contact

• Title: Dr Patrick Butler
• Organization: University Hospital Southampton

patrick.butler@uhs.nhs.uk

81205662

Study Officials

• Patrick Butler

  Unvistery Hospital Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: October 18, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)