Patients Comfort During Highflow Oxygen Therapy With Asymmetrical Prongs

NCT06778291 | Completed DMC

• 1 other identifier: COMFOXY-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

High-flow nasal cannula (HFNC) is a respiratory support device widely used to manage acute respiratory failure (ARF) and recommended in different patient populations according to the last European Respiratory Society and European Society of Intensive Care Medicine guidelines. HFNC delivers heated and humidified oxygen that facilitates airway secretion clearance, and its use is associated with improvement of oxygenation and reduction of airway dead space compared to standard oxygen therapy. Finally, all these beneficial effects result in a greater comfort experienced by the patient, as compared either to standard oxygen therapy or non-invasive ventilation.

Conditions

Respiratory Failure

Keywords

high flow oxygen therapy; oxygen therapy

Outcome Measures

Primary Outcomes (1)

• COMFORT

  The present pilot study aims at assessing patient comfort during oxygen support with asymmetrical HFNCs, comparing two cannula sizes, one completely occluding the nostril and one a size smaller. The evaluation scale is the 0-10 numeric rating scale (NRS). Each step will be 60 min long and a 10-min 'wash-out' phase with Venturi mask support will be required before each step.

  After 60 minutes of HFNC support

Secondary Outcomes (3)

• DYSPNEA

  After 60 minutes of HFNC support

• LUNG AERATION

  After 60 minutes of HFNC support

• Respiratory rate, peripheral oxygen saturation, gas-changes, ratio between PaO2 and inspiratory oxygen fraction, ventilatory ratio [10]

  After 60 minutes of HFNC support

Study Arms (2)

OCCLUDING HFNC then SMALLER HFNC

Randomization will be performed immediately after the enrollment of the patient, before starting HFNC support. All patients will receive HFNC therapy through the asymmetrical interface Optiflow® Duet system (Fisher \& Paykel Healthcare, Auckland, New Zealand). According to a software-generated blocked random sequence, patients will be assigned to the larger cannula treatment and then the smaller cannula treatment or viceversa.

SMALLER HFNC then OCCLUDING HFNC

Randomization will be performed immediately after the enrollment of the patient, before starting HFNC support. All patients will receive HFNC therapy through the asymmetrical interface Optiflow® Duet system (Fisher \& Paykel Healthcare, Auckland, New Zealand). According to a software-generated blocked random sequence, patients will be assigned to the larger cannula treatment and then the smaller cannula treatment or viceversa.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to the ICU and requiring oxygen support for any reason.

You may qualify if:

• \- adult patients (\>18 years old) requiring oxygen support in the ICU

You may not qualify if:

• pregnancy;
• presence of tracheostomy;
• contraindications to EIT;
• contraindications to HFNCs positioning,
• clinical evidence of nare occlusion (patient will be asked to deeply inspire from the nose while researcher occludes manually each nostril alternately: if unable to breath from the free nare with the other one occluded, patient will not be eligible for participating to the study), or very small nare fitting only the S-sized Duet cannulas;
• patients requiring nasogastric tubes for mandatory clinical reasons, i.e., delayed gastric emptying, upper abdominal surgery.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (2)

Istituto di Anestesia e Rianimazione, ISTAR 3

Padua, Italy, 35100, Italy

Location

Azienda Ospedale Università Padova

Padua, Padova, 35126, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 16, 2025
• Study Start: February 25, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)