The Incidence of Respiratory Symptoms Associated With the Use of HFNO

NCT ID: NCT03619148

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-04-26

Brief Summary

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Optiflow (high flow humified nasal oxygen) is used in several settings frequently (ICU, during elective general anaesthesia- commonly here on the TOE list, in certain ENT patients, and more commonly now in obese or obstetric patients for preoxygenation). To the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in November 2017 using PubMed and Google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). The investigators were unable to find any existing research that examined the days following HFNO use and specifically looked for minor side effects) The investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post HFNO.

THe investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.

Detailed Description

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The study aims to evaluate what is the frequency and severity of respiratory tract symptoms following the use of high flow nasal humidified oxygen? Participants will be from 2 sub groups:

1. Patients already undergoing TOE (as this is the most common and consistent group who have optiflow- about 4-5 patients per week)
2. Volunteers (staff) who would agree to experience the optiflow whilst awake for the same period as those undergoing TOE

The study will involve a 7 day follow up survey to see if they had experienced complications (runny nose, nasal discomfort, sore throat, epistaxis), what their severity was and how long they lasted for.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

2 sub group will be recruited:

1. patient undergoing TOE
2. Staff volunteers
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-Flow Humidified Nasal Oxygen - TOE participants

High-Flow Humidified Nasal Oxygen - standard care

Group Type OTHER

High-Flow Humidified Nasal Oxygen

Intervention Type DEVICE

High-Flow Humidified Nasal Oxygen

High-Flow Humidified Nasal Oxygen

High-Flow Humidified Nasal Oxygen - staff volunteers

Group Type ACTIVE_COMPARATOR

High-Flow Humidified Nasal Oxygen

Intervention Type DEVICE

High-Flow Humidified Nasal Oxygen

Interventions

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High-Flow Humidified Nasal Oxygen

High-Flow Humidified Nasal Oxygen

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Volunteers (staff) - from the anaesthetics department and willing to be exposed to HFNO
2. Patients listed for all those undergoing elective TOE requiring sedation and use of HFNO
3. present at Torbay Hospital
4. Greater than 18 years of age. No upper age limit
5. Able to give informed consent

Exclusion Criteria

1. patient refusal
2. lack of capacity
3. poor understanding of English
4. respiratory tract symptoms
5. blocked nostrils
6. current or recurrent epistaxis
7. nasal steroid treatment
8. Ages \<18 years
9. Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Torbay and South Devon NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Flowers, Dr

Role: PRINCIPAL_INVESTIGATOR

Torbay and South Devon NHS Foundation Trust

Locations

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Torbay Hospital

Torquay, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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18/LO/1133

Identifier Type: OTHER

Identifier Source: secondary_id

IRAS-233721

Identifier Type: -

Identifier Source: org_study_id

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