AzTrials
AzTrials

High Flow Nasal CannulaHILOOPNCT04965844

Closed-loop Oxygen Control for High Flow Nasal Therapy

A study testing Oxygen close-loop in people with High Flow Nasal Cannula and Oxygen Therapy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High Flow Nasal Cannula, Oxygen Therapy, Hypoxemia
What is being tested?
Oxygen close-loop
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteSpain
Study dates
27 Apr 2021to 10 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

Other trials in Spain

About this study

Official 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)

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.

Being tested
Oxygen close-loop, No intervention
Keywords
High flow nasal cannula, Nasal high flow, Oxygen close-loop, Hypoxemia, Hyperoxemia
Medical subject headings
Hypoxia, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen close-loopDevice

    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 interventionDevice

    Manual FiO2 adjustment according to SpO2 values

Study groups in NCT04965844
Study groupRoleWhat they receive
Oxygen close-loopExperimentalFour hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.
Receives: Device: Oxygen close-loop
Manual FiO2 adjustmentActive comparatorFour hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.
Receives: Device: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of time spent in optimal SpO2 range

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

    Measured: 4 hours

Secondary outcomes (12)

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

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

    Measured: 4 hours

  2. Percentage of time spent out of range

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

    Measured: 4 hours

  3. Percentage of time with SpO2 signal available

    Time with SpO2 signal available

    Measured: 4 hours

  4. Mean SpO2/FiO2

    Mean oxygenation value

    Measured: 4 hours

  5. ROX index

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

    Measured: 4 hours

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

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

    Measured: 4 hours

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

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

    Measured: 4 hours

  8. Mean FiO2

    Mean fraction of inspired oxygen

    Measured: 4 hours

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

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

    Measured: 4 hours

  10. Number of manual adjustments

    Frequency of manual adjustments of FiO2

    Measured: 4 hours

  11. Number of alarms

    Frequency of alarms

    Measured: 4 hours

  12. Patient comfort

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

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2021
  2. Study start27 Apr 2021
  3. Primary completion10 Aug 2021
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04965844
Sponsor's protocol ID
PR(AG)539/2020
Acronym
HILOOP
Status last verified
Oct 2021
First submitted
4 May 2021
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1):1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.

    PubMed 28729473

  • Helmerhorst HJ, Roos-Blom MJ, van Westerloo DJ, de Jonge E. Association Between Arterial Hyperoxia and Outcome in Subsets of Critical Illness: A Systematic Review, Meta-Analysis, and Meta-Regression of Cohort Studies. Crit Care Med. 2015 Jul;43(7):1508-19. doi: 10.1097/CCM.0000000000000998.

    PubMed 25855899

  • Arnal JM, Garnero A, Novotni D, Corno G, Donati SY, Demory D, Quintana G, Ducros L, Laubscher T, Durand-Gasselin J. Closed loop ventilation mode in Intensive Care Unit: a randomized controlled clinical trial comparing the numbers of manual ventilator setting changes. Minerva Anestesiol. 2018 Jan;84(1):58-67. doi: 10.23736/S0375-9393.17.11963-2. Epub 2017 Jul 5.

    PubMed 28679200

  • Roca O, Caritg O, Santafe M, Ramos FJ, Pacheco A, Garcia-de-Acilu M, Ferrer R, Schultz MJ, Ricard JD. Closed-loop oxygen control improves oxygen therapy in acute hypoxemic respiratory failure patients under high flow nasal oxygen: a randomized cross-over study (the HILOOP study). Crit Care. 2022 Apr 14;26(1):108. doi: 10.1186/s13054-022-03970-w.

    PubMed 35422002

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen close-loop in people with High Flow Nasal Cannula and Oxygen Therapy, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time spent in optimal SpO2 range (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04965844, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in