The Incidence of Respiratory Symptoms Associated With the Use of HFNO

NCT03619148 | Completed

• 2 other identifiers: IRAS-23372118/LO/1133
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory tract symptoms

  telephone survey after 7 days

  7 days

Secondary Outcomes (1)

• severity of respiratory tract symptoms

  7 days

Study Arms (2)

High-Flow Humidified Nasal Oxygen - TOE participants

OTHER

High-Flow Humidified Nasal Oxygen - standard care

Device: High-Flow Humidified Nasal Oxygen

High-Flow Humidified Nasal Oxygen

ACTIVE COMPARATOR

High-Flow Humidified Nasal Oxygen - staff volunteers

Device: High-Flow Humidified Nasal Oxygen

Interventions

High-Flow Humidified Nasal Oxygen DEVICE

High-Flow Humidified Nasal Oxygen

High-Flow Humidified Nasal Oxygen; High-Flow Humidified Nasal Oxygen - TOE participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust: lead

Study Sites (1)

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Katie Flowers, Dr

  Torbay and South Devon NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 sub group will be recruited: 1. patient undergoing TOE 2. Staff volunteers

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 7, 2018
• Study Start: September 5, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)