Flow veRsus OxygeNaTion In acutE ReSpiratory Failure

NCT03223948 | Unknown

• 1 other identifier: GN16RM134
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• Patient satisfaction scores

  75 minutes after start of study

• Number of patients unable to tolerate 'Optiflow' device

  0 to 75 minutes after start of study

Study Arms (3)

30 litres per minute

ACTIVE COMPARATOR

High flow nasal oxygen delivery device 'Optiflow'

Device: 'Optiflow'

45 litres per minute

ACTIVE COMPARATOR

High flow nasal oxygen delivery device 'Optiflow'

Device: 'Optiflow'

60 litres per minute

ACTIVE COMPARATOR

High flow nasal oxygen delivery device 'Optiflow'

Device: 'Optiflow'

Interventions

'Optiflow' DEVICE

High flow nasal oxygen delivery device 'Optiflow'

30 litres per minute; 45 litres per minute; 60 litres per minute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 18540928 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Malcolm Sim, MD, MB ChB

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malcolm J watson, PhD, MB ChB

CONTACT

0141 452 3430; mwatson@doctors.org.uk

Malcolm Sim, MD, MB ChB

CONTACT

0141 452 3033; malcolm.sim@ggc.scot.nhs.uk

Study Design

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

Model Details: 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%.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: July 21, 2017
• Study Start: May 10, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)