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NCT03766646 Clinical Trial

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

Unrecognized Condition Clinical Trial

Official title:
Preoxygenation With High Flow Nasal Oxygenation Using Optiflow - Does Speech Have an Effect on The End Tidal Oxygen Achieved When Compared to Closed Mouth Nasal Breathing?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03766646
Other study ID # RHM CR10369
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 18, 2018
Est. completion date November 16, 2018

Study information
Verified date October 2020
Source University Hospital Southampton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date November 16, 2018
Est. primary completion date November 16, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - BMI 18-35, ASA category 1 or 2 Exclusion Criteria: - Inability to read/ follow instructions, Heavily sedated

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Optiflow
45l.min oxygen

Locations
Country Name City State
United Kingdom University Hospital Southampton Southampton Hants

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary End Tidal Oxygen Fraction Oxygen fraction in first expired breath post preoxygenation At the end of 3 minutes preoxygenation
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