NCT04965844

Closed-loop Oxygen Control for High Flow Nasal Therapy

Safety and Efficacy of a Closed-loop Oxygen Control for High Flow Nasal Therapy in ICU Patients: a Randomized Cross-over Study (The HILOOP Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. Current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (SpO2) in the target range and avoid hypoxemia and hyperoxemia. 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 ICU patients treated with HFNT.

Conditions

• High Flow Nasal Cannula
• Oxygen Therapy
• Hypoxemia
• Hyperoxemia
• Acute Respiratory Failure
• Respiratory Insufficiency

Interventions

Type	Name	Description
DEVICE	Oxygen close-loop	The Automatic FiO2 option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the Oxygen setting to keep the patient's SpO2 in the target range.
DEVICE	No intervention	Manual FiO2 adjustment according to SpO2 values

Timeline

• Start date: 2021-04-27
• Primary completion: 2021-08-10
• Completion: 2021-08-10
• First posted: 2021-07-16
• Last updated: 2021-12-09

Locations

1 site across 1 country: Spain