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Clinical Trials/NCT03619148
NCT03619148CompletedNot Applicable

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

Torbay and South Devon NHS Foundation Trust2 sites in 1 country30 target enrollmentStarted: September 5, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Incidence of respiratory tract symptoms

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

Incidence of respiratory tract symptoms

Time Frame: 7 days

telephone survey after 7 days

Secondary Outcomes

  • severity of respiratory tract symptoms(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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