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

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?

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?

Study Overview

• Status: Completed
• Conditions: Unrecognized Condition
• Intervention / Treatment: Device: Optiflow

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hants
    • Southampton, Hants, United Kingdom, SO16 6YD
      • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• BMI 18-35, ASA category 1 or 2

Exclusion Criteria:

• Inability to read/ follow instructions, Heavily sedated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Optiflow; 45l.min oxygen; Other Names: HFNO, High Flow Nasal Oxygen
Active Comparator: 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.	Device: Optiflow; 45l.min oxygen; Other Names: HFNO, High Flow Nasal Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End Tidal Oxygen Fraction	Oxygen fraction in first expired breath post preoxygenation	At the end of 3 minutes preoxygenation

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Investigators: Principal Investigator: Patrick Butler, Unvistery Hospital Southampton

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 16, 2018

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Speech; Preoxygenation; Optiflow; High Flow Nasal Oxygen
• Other Study ID Numbers: RHM CR10369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No