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Completed

NCT Number: NCT04965844

Closed-loop Oxygen Control for High Flow Nasal Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen close-loop

Device

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.

No Intervention

Device

Manual FiO2 adjustment according to SpO2 values

Primary outcomes

  1. Percentage of time spent in optimal SpO2 range

    Time frame: 4 hours

    The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.

Secondary outcomes

  1. Percentage of time spent in sub-optimal SpO2 range

    Time frame: 4 hours

    SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)

  2. Percentage of time spent out of range

    Time frame: 4 hours

    Above or below the suboptimal limits specified at the begginning of the study

  3. Percentage of time with SpO2 signal available

    Time frame: 4 hours

    Time with SpO2 signal available

  4. Mean SpO2/FiO2

    Time frame: 4 hours

    Mean oxygenation value

  5. ROX index

    Time frame: 4 hours

    Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate

  6. Percentage of time with SpO2 below 88 and 85 percent

    Time frame: 4 hours

    Duration of time with SpO2 <85 percent and <88 percent, respectively

  7. Number of events with SpO2 below 88 and 85 percent

    Time frame: 4 hours

    Frequency of SpO2 decreases <85 percent and <88 percent, respectively

  8. Mean FiO2

    Time frame: 4 hours

    Mean fraction of inspired oxygen

  9. Percentage of time with FiO2 below 40 percent and above 60%

    Time frame: 4 hours

    Percentage of time that FiO2 is <40 percent and >60 percent, respectively

  10. Number of manual adjustments

    Time frame: 4 hours

    Frequency of manual adjustments of FiO2

  11. Number of alarms

    Time frame: 4 hours

    Frequency of alarms

  12. Patient comfort

    Time frame: 4 hours

    Comfort score by visual analogic scale (from 0 to 10)

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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)

Acronym: HILOOP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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