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Completed

NCT Number: NCT03619148

The Incidence of Respiratory Symptoms Associated With the Use of HFNO

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

About this study

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:

  • Patients already undergoing TOE (as this is the most common and consistent group who have optiflow- about 4-5 patients per week)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patient refusal
  • lack of capacity
  • poor understanding of English
  • respiratory tract symptoms
  • blocked nostrils
  • current or recurrent epistaxis
  • nasal steroid treatment
  • Ages <18 years
  • Unable to give informed consent

Treatment and study plan

High-Flow Humidified Nasal Oxygen

Device

High-Flow Humidified Nasal Oxygen

Primary outcomes

  1. Incidence of respiratory tract symptoms

    Time frame: 7 days

    telephone survey after 7 days

Secondary outcomes

  1. severity of respiratory tract symptoms

    Time frame: 7 days

    telephone survey after 7 days

Sponsors and collaborators

Lead sponsor

Torbay and South Devon NHS Foundation Trust

Other

Registry information

Official study title

The Incidence and Severity of Upper Respiratory Tract Symptoms Associated With The Use of High-Flow Humidified Nasal Oxygen (HFNO)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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