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

NCT ID: NCT03766646

Last Updated: 2020-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2018-11-16

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Unrecognized Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Optiflow

Intervention Type DEVICE

45l.min oxygen

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.

Group Type ACTIVE_COMPARATOR

Optiflow

Intervention Type DEVICE

45l.min oxygen

Interventions

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Optiflow

45l.min oxygen

Intervention Type DEVICE

Other Intervention Names

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HFNO, High Flow Nasal Oxygen

Eligibility Criteria

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Inclusion Criteria

* BMI 18-35, ASA category 1 or 2

Exclusion Criteria

* Inability to read/ follow instructions, Heavily sedated
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Butler

Role: PRINCIPAL_INVESTIGATOR

Unvistery Hospital Southampton

Locations

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University Hospital Southampton

Southampton, Hants, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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RHM CR10369

Identifier Type: -

Identifier Source: org_study_id