Closed-loop Oxygen Control for High Flow Nasal Therapy

Not Applicable

Completed

• Conditions: Oxygen Therapy; Hyperoxemia; Respiratory Insufficiency; High Flow Nasal Cannula; Hypoxemia; Acute Respiratory Failure
• Interventions: Device: No intervention; Device: Oxygen close-loop

• Registration Number: NCT04965844
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-27
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Adult (>17yo) patients admitted to the ICU treated with HFNT for at least 8h
• Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
• Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation.

Exclusion Criteria

• Patient with indication for immediate continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), or invasive mechanical ventilation
• Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
• Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange colour bar)
• Severe acidosis (pH ≤ 7.30)
• Pregnant woman
• Patients deemed at high risk for need of mechanical ventilation within the next 8 hours
• Chronic or acute dyshemoglobinemia: methemoglobin, carbon monoxide (CO) poisoning, sickle cell disease
• Tracheotomised patient
• Formalized ethical decision to withhold or withdraw life support
• Patient under guardianship
• Patient deprived of liberties
• Patient included in another interventional research study under consent
• Patient already enrolled in the present study in a previous episode of acute respiratory failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Manual FiO2 adjustment	No intervention	Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.
Oxygen close-loop	Oxygen close-loop	Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.

Primary Outcome Measures

Name	Time	Method
Percentage of time spent in optimal SpO2 range	4 hours	The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary Outcome Measures

Name	Time	Method
ROX index	4 hours	Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate
Percentage of time spent out of range	4 hours	Above or below the suboptimal limits specified at the begginning of the study
Percentage of time with SpO2 signal available	4 hours	Time with SpO2 signal available
Mean SpO2/FiO2	4 hours	Mean oxygenation value
Percentage of time spent in sub-optimal SpO2 range	4 hours	SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Percentage of time with SpO2 below 88 and 85 percent	4 hours	Duration of time with SpO2 \<85 percent and \<88 percent, respectively
Number of events with SpO2 below 88 and 85 percent	4 hours	Frequency of SpO2 decreases \<85 percent and \<88 percent, respectively
Mean FiO2	4 hours	Mean fraction of inspired oxygen
Percentage of time with FiO2 below 40 percent and above 60%	4 hours	Percentage of time that FiO2 is \<40 percent and \>60 percent, respectively
Number of manual adjustments	4 hours	Frequency of manual adjustments of FiO2
Number of alarms	4 hours	Frequency of alarms
Patient comfort	4 hours	Comfort score by visual analogic scale (from 0 to 10)

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain