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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06398951




Registration number
NCT06398951
Ethics application status
Date submitted
24/03/2024
Date registered
3/05/2024
Date last updated
3/05/2024

Titles & IDs
Public title
HFNC vs Two Nare HFNC in Extubated Patients
Scientific title
A Comparison of Conventional High Flow Nasal Cannula vs Two-nare Size High Flow Nasal Cannula: A Randomized Crossover Trial in Extubated Patients
Secondary ID [1] 0 0
87400
Universal Trial Number (UTN)
Trial acronym
HFNC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen Deficiency 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Two nare high flow nasal cannula

Active comparator: Two Nare (Duet) high flow nasal cannula - Recently a new mode of high flow oxygen therapy has presented on the market where the cannula of high flow have different diameters. Left cannula larger in diameter than the right. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-60 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient.

Placebo comparator: Conventional High flow nasal cannula - Conventional high flow nasal cannula that has been used for many years will be compared with two-nare high flow nasal cannula. The two nare nasal cannula will be used for 30 minutes to assess the gas exchange, hemodynamic parameters, the tolerance and comfort of the device to the patient.


Treatment: Devices: Two nare high flow nasal cannula
Recently a new mode of high flow oxygen therapy has presented on the market where the prongs of high flow have different diameters .These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood gasses (PaO2 in mmHg)
Timepoint [1] 0 0
30 minutes each for a total of one hour.
Primary outcome [2] 0 0
Blood gasses (PaCO2 in mmHg)
Timepoint [2] 0 0
30 minutes each for a total of one hour.
Primary outcome [3] 0 0
Blood gasses (SaO2 percentage)
Timepoint [3] 0 0
30 minutes each for a total of one hour.
Secondary outcome [1] 0 0
blood pressure (mmHg)
Timepoint [1] 0 0
30 minutes each for a total of one hour.
Secondary outcome [2] 0 0
Respiratory rate (breaths per minute)
Timepoint [2] 0 0
30 minutes each for a total of one hour.
Secondary outcome [3] 0 0
Tolerance as assessed by a 5-point Likert scale ranging from 0-4.
Timepoint [3] 0 0
30 minutes each for a total of one hour.
Secondary outcome [4] 0 0
Comfort as assessed by a 5-point Likert scale ranging from 1-5.
Timepoint [4] 0 0
30 minutes each for a total of one hour.

Eligibility
Key inclusion criteria
* All intubated patients imminently requiring extubation with family consent for admittance into the trial that meet the follow criteria:
* P/F ratio between > 150 prior to extubation
* Has a functional arterial catheter to allow sample of arterial blood gasses.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients being extubated due to withdrawal of therapy Patients being extubated, that are expected to imminently die post extubation P/F Ratio :< 150 Patients extubated on to non-invasive ventilation Patients with known epistaxis or nasal surgery.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
3199 - Frankston

Funding & Sponsors
Primary sponsor type
Government body
Name
Peninsula Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. These HFNC are subsequently shown to be useful in several clinical conditions in critically ill patients including respiratory failure due to hypoxia, hypercapnia (exacerbation of chronic obstructive lung disease), or post-extubation, pre-intubation oxygenation, and others.

Recently a new mode of high flow oxygen therapy has been presented on the market where the prongs of high flow have two different diameters. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. This positive pressure could help in gas exchange of patients who need more oxygen. These devices are approved by the Therapeutic Goods Administration (TGA); the medicine and therapeutic regulatory agency of the Australian Government.

Our aim is to compare the two size nare high flow nasal cannula with conventional high flow nasal cannula in extubated patients in intensive care unit in a randomised crossover trial. The comparison will include arterial blood gasses, physiological data including heart rate, respiratory rate, saturations as well as comfort and tolerance of the patients to two size nare high flow nasal cannuale.
Trial website
https://clinicaltrials.gov/study/NCT06398951
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
RAVINDRANATH TIRUVOIPATI, PhD
Address 0 0
Peninsula Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06398951