Respiratory Failure Clinical Trial
— FrontiersOfficial title:
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Elizabeth University Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde | Fisher and Paykel Healthcare |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
Recruiting |
NCT03662438 -
HOPE (Home-based Oxygen [Portable] and Exercise) for Patients on Long Term Oxygen Therapy (LTOT)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04030208 -
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation
|
N/A | |
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT04668313 -
COVID-19 Advanced Respiratory Physiology (CARP) Study
|
||
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04505592 -
Tenecteplase in Patients With COVID-19
|
Phase 2 | |
Completed |
NCT03943914 -
Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
|
N/A | |
Active, not recruiting |
NCT03472768 -
The Impact of Age-dependent Haptoglobin Deficiency on Plasma Free Hemoglobin Levels During Extracorporeal Membrane Oxygenation Support
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT02542423 -
Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure.
|
N/A | |
Completed |
NCT02265198 -
Relationship of Pulmonary Contusion to Pulmonary Inflammation and Incidence of Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT01885442 -
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A | |
Completed |
NCT01659268 -
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
|
N/A | |
Terminated |
NCT01333059 -
Cycling of Sedative Infusions in Critically Ill Pediatric Patients
|
N/A | |
Completed |
NCT01204281 -
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
|
Phase 4 |