Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374589
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-16
Brief Title:
Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients CLOUDHFOT
Sponsor:
Başakşehir Çam Sakura City Hospital
Organization:
Başakşehir Çam Sakura City Hospital
Study Overview
Official Title:
Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients CLOUDHFOT- a Randomized Cross-over Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
CLOUDHFOT
Brief Summary:
High flow nasal oxygen therapy HFNO is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure The high humidified gas flow supports patients work of breathing reduces dead space ventilation and improves functional residual capacity while using an unobtrusive patients face interface Mauri et al 2017 Möller et al 2017
As hyperoxia is considered not desirable Barbateskovic et al 2019 during any oxygen therapy the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96 in patients without hypercapnia risk and of 88-92 if a risk of hypercapnia is present ODriscoll et al 2017 Beasley et al 2015 In most institutions the standard of care is to manually adapt the FiO2 although patients frequently have a SpO2 value outside the target range
A new closed loop oxygen controller designed for HFNO was recently developed Hamilton Medical Bonaduz Switzerland The clinician sets SpO2 targets and the software option adjusts FiO2 to keep SpO2 within the target ranges The software option offers some alarms on low and high SpO2 and high FiO2 Given the capability on the one hand to quickly increase FiO2 in patients developing sudden and profound hypoxia and on the other hand of automatically preventing hyperoxia in patients improving their oxygenation such a system could be particularly useful in patients treated with HFNO
A short-term 4 hours vs 4 hours crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy Roca et al 2022 Due to its simplicity HFNO is increasingly used outside the ICU during transport and in the Emergency Room ER This environment poses specific challenges as patients may deteriorate very quickly and depending on patients flow healthcare providers can easily be overwhelmed We thus propose to evaluate closed loop controlled HFNO in ER patients
The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO
As hyperoxia is considered not desirable Barbateskovic et al 2019 during any oxygen therapy the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96 in patients without hypercapnia risk and of 88-92 if a risk of hypercapnia is present ODriscoll et al 2017 Beasley et al 2015 In most institutions the standard of care is to manually adapt the FiO2 although patients frequently have a SpO2 value outside the target range
A new closed loop oxygen controller designed for HFNO was recently developed Hamilton Medical Bonaduz Switzerland The clinician sets SpO2 targets and the software option adjusts FiO2 to keep SpO2 within the target ranges The software option offers some alarms on low and high SpO2 and high FiO2 Given the capability on the one hand to quickly increase FiO2 in patients developing sudden and profound hypoxia and on the other hand of automatically preventing hyperoxia in patients improving their oxygenation such a system could be particularly useful in patients treated with HFNO
A short-term 4 hours vs 4 hours crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy Roca et al 2022 Due to its simplicity HFNO is increasingly used outside the ICU during transport and in the Emergency Room ER This environment poses specific challenges as patients may deteriorate very quickly and depending on patients flow healthcare providers can easily be overwhelmed We thus propose to evaluate closed loop controlled HFNO in ER patients
The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO
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