Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03976180
Status:
UNKNOWN
Last Update Posted:
2020-05-21
First Post:
2019-05-24
Brief Title:
High-flow Oxygen for Vaso-occlusive Pain Crisis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Multicentre Prospective Randomized Multi-arm Multi-stage Clinical Trial of High-flow Oxygen for Vaso-occlusive Pain Crisis in Adult Patients With Sickle Cell Disease
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSONE
Brief Summary:
Sickle cell disease SCD is characterized by recurrent vaso-occlusive pain crisis VOC which may evolve to acute chest syndrome ACS the most common cause of death among adult patients with SCD Currently there is no safe and effective treatment to abort VOC or prevent secondary ACS Management of VOC mostly involve a symptomatic approach including hydration analgesics transfusion and incentive spirometry which was investigated in a very limited number of patients 30
The polymerisation of HbS is one major feature in the pathogenesis of vaso-occlusion Among factors determining the rate and extent of HbS polymer formation the hypoxic stimulus is one of the most potent and readily alterable Current guidelines recommend oxygen therapy in patients with VOC in order to maintain a target oxygen saturation of 95 Low-flow nasal oxygen LFNO is routinely used to achieve this normoxia approach particularly in patients at risk of secondary ACS because they may experience acute desaturation In contrast various case series suggest a potential beneficial role of intensified oxygen therapy targeting hyperoxia for the management of VOC particularly with the use of hyperbaric oxygen but the latter is difficult to implement in routine clinical practice
A recent high-flow nasal oxygen HFNO technology allows the delivery of humidified gas at high fraction of inspired oxygen FiO2 through nasal cannula The FiO2 can be adjusted up to 100 allowing hyperoxia that may reverse sickling and the flow can be increased up to 60 Lmin which generates positive airway pressure and dead space flushing that may prevent evolution of VOC towards ACS by alleviating atelectasis and opioid-induced hypercapnia In patients with acute respiratory failure HFNO has been shown to improve patients comfort oxygenation and survival as compared to standard oxygen or non-invasive ventilation
The aim of the present study is to test the efficacy and safety of HFNO for the management of VOC and prevention of secondary ACS The investigators will use a multi-arm multi-stage MAMS design to achieve these goals HFNO will be delivered through AIRVO 2 Fisher and Paykel Healthcare New Zealand a device that incorporates a turbine allowing its use in hospital wards
The polymerisation of HbS is one major feature in the pathogenesis of vaso-occlusion Among factors determining the rate and extent of HbS polymer formation the hypoxic stimulus is one of the most potent and readily alterable Current guidelines recommend oxygen therapy in patients with VOC in order to maintain a target oxygen saturation of 95 Low-flow nasal oxygen LFNO is routinely used to achieve this normoxia approach particularly in patients at risk of secondary ACS because they may experience acute desaturation In contrast various case series suggest a potential beneficial role of intensified oxygen therapy targeting hyperoxia for the management of VOC particularly with the use of hyperbaric oxygen but the latter is difficult to implement in routine clinical practice
A recent high-flow nasal oxygen HFNO technology allows the delivery of humidified gas at high fraction of inspired oxygen FiO2 through nasal cannula The FiO2 can be adjusted up to 100 allowing hyperoxia that may reverse sickling and the flow can be increased up to 60 Lmin which generates positive airway pressure and dead space flushing that may prevent evolution of VOC towards ACS by alleviating atelectasis and opioid-induced hypercapnia In patients with acute respiratory failure HFNO has been shown to improve patients comfort oxygenation and survival as compared to standard oxygen or non-invasive ventilation
The aim of the present study is to test the efficacy and safety of HFNO for the management of VOC and prevention of secondary ACS The investigators will use a multi-arm multi-stage MAMS design to achieve these goals HFNO will be delivered through AIRVO 2 Fisher and Paykel Healthcare New Zealand a device that incorporates a turbine allowing its use in hospital wards
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None