Flow veRsus OxygeNaTion In acutE ReSpiratory Failure (Frontiers)

A Dose Finding Study to Determine the Optimal Flow Rate and Oxygen Concentration Using High Flow Nasal Oxygenation for Patients With Respiratory Failure.

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: 'Optiflow'

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Malcolm Sim, MB ChB; Phone Number: 01414523430; Email: malcolm.sim@ggc.scot.nhs.uk
    • Contact: Malcolm j watson, MBchB; Phone Number: 01414523430; Email: mwatson@doctors.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	75 minutes after start of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction scores	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	75 minutes after start of study
Number of patients unable to tolerate 'Optiflow' device	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).	0 to 75 minutes after start of study

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Malcolm Sim, MD, MB ChB, NHS Greater Glasgow and Clyde

Publications and helpful links

General Publications

• Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: GN16RM134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data not relevant to individual patient after episode of respiratory failure

Drug and device information, study documents

• 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