Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Flow veRsus OxygeNaTion In acutE ReSpiratory Failure (Frontiers)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03223948
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
High flow nasal oxygen therapy has been widely used but guidelines as to the optimal starting flow rate and oxygen percentage are not available. Prolonged exposure to an inappropriately high oxygen concentration should be avoided as there is increasing evidence that the production of oxygen free radicals can lead to lung damage. This pilot dose finding study will determine the optimal flow rate and oxygen concentration using HFNO2 for patients with respiratory failure requiring low, medium or high oxygen concentration from conventional low flow devices. An assessment will also be made of comfort and compliance with HFNO2.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: 'Optiflow' Not Applicable

Detailed Description:

The study will recruit a total of between 180 and 270 patients across three hospital sites mainly from high dependence units.

The patients recruited will be stratified into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).

All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.

End points:

Minimal FiO2 required to maintain saturation above 94% for patients with low, medium and high recruitment oxygen requirements for 30 litres, 45 litres and 60 litres per minute. Use Kruskal Wallis to compare the median FiO2 requirements of those patients who recruited with low, medium and high O2 requirement.

Obtain dose response curve 02 saturation against FiO2 for 3 different flow rates for each of the recruitment 02 requirements and use regression modelling to find best fit dose FiO2 response O2 saturation curves

Patient satisfaction scores and number of patients unable to tolerate the three flow rates in each of the three starting groups and flow rates.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The patients recruited will be divided into 3 groups according to their oxygen (O2) requirements at recruitment (low, medium and high).

All recruited patients will then be given supplementary O2 using the Optiflow system. Patients from all three recruitment oxygen requirements (low, medium and high) will be randomised to 30 litres, 45 litres or 60 litres per minute with initial a fractional inspired O2 concentration(FiO2) of 0.90 (90% oxygen). The FiO2 is then decreased in 0.05 increments every 5 minutes and the minimum oxygen saturation recorded until it reaches 94%.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Finding Study to Determine the Optimal Flow Rate and Oxygen Concentration Using High Flow Nasal Oxygenation for Patients With Respiratory Failure.
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 30 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
Device: 'Optiflow'
High flow nasal oxygen delivery device 'Optiflow'

Active Comparator: 45 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
Device: 'Optiflow'
High flow nasal oxygen delivery device 'Optiflow'

Active Comparator: 60 litres per minute
High flow nasal oxygen delivery device 'Optiflow'
Device: 'Optiflow'
High flow nasal oxygen delivery device 'Optiflow'




Primary Outcome Measures :
  1. Median FiO2 (%) needed to be delivered via high flow therapy (Optiflow), at 3 different flow rates, to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in 3 groups of patients with acute respiratory failure [ Time Frame: 75 minutes after start of study ]
    The median fraction inspired concentration ( FiO2) required to maintain an oxygen saturation ≥94 % and respiratory rate ≤30 in patients with respiratory failure using 'Optiflow' device at three different oxygen flow rates 30 litres 45 litres and 60 litres per minute flow within the three stratified groups of low, median and high oxygen requirements (at recruitment to the study).


Secondary Outcome Measures :
  1. Patient satisfaction scores [ Time Frame: 75 minutes after start of study ]

    Comfort of new device when delivering oxygen with each oxygen flow rate:

    comfort, bloating, dry mouth, ability to hear and speak in comparison to conventional oxygen therapy


  2. Number of patients unable to tolerate 'Optiflow' device [ Time Frame: 0 to 75 minutes after start of study ]
    Failure to complete the 75 minutes with 'Optiflow' at three different oxygen flow rates (30 litres 45 litres and 60 litres per minute flow) within the three stratified groups of low median and high oxygen requirements (at recruitment to study).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient aged 18-80 at time of recruitment to study) Able to give their own consent (4 "A" Test score of 0 if capacity questionable) Acute respiratory failure but no significant deterioration in the previous hour Receiving conventional oxygen therapy (Hudson, Venturi, non-rebreathing mask or equivalent) up to a maximum of 90% Oxygen saturation ≥ 94% and respiratory rate ≤30

Exclusion Criteria:

Type II respiratory failure (chloride ≤95 and bicarbonate ≥35, on an arterial blood gas or venous sample within 4 weeks) Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V) Pregnancy Heart failure (NYHA Grade III or IV) Decreased GCS Cardiovascular instability (systolic BP ≤90 or heart rate ≥130) Pulmonary embolism Unable to give informed consent Contraindication to receiving high flow nasal oxygen

  • Nasal obstruction
  • Previous bleomycin administration
  • Base of skull fracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223948


Contacts
Layout table for location contacts
Contact: Malcolm J watson, PhD, MB ChB 0141 452 3430 mwatson@doctors.org.uk
Contact: Malcolm Sim, MD, MB ChB 0141 452 3033 malcolm.sim@ggc.scot.nhs.uk

Locations
Layout table for location information
United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Contact: Malcolm Sim, MB ChB    01414523430    malcolm.sim@ggc.scot.nhs.uk   
Contact: Malcolm j watson, MBchB    01414523430    mwatson@doctors.org.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Fisher and Paykel Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Malcolm Sim, MD, MB ChB NHS Greater Glasgow and Clyde

Publications:
Layout table for additonal information
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03223948     History of Changes
Other Study ID Numbers: GN16RM134
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data not relevant to individual patient after episode of respiratory failure

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases