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Closed-loop Oxygen Control for High Flow Nasal Therapy (HILOOP)

Primary Purpose

High Flow Nasal Cannula, Oxygen Therapy, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oxygen close-loop
No intervention
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Flow Nasal Cannula focused on measuring High flow nasal cannula, Nasal high flow, Oxygen close-loop, Hypoxemia, Hyperoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxygen close-loop

Manual FiO2 adjustment

Arm Description

Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.

Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2021
Last Updated
November 26, 2021
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04965844
Brief Title
Closed-loop Oxygen Control for High Flow Nasal Therapy
Acronym
HILOOP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
August 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Flow Nasal Cannula, Oxygen Therapy, Hypoxemia, Hyperoxemia, Acute Respiratory Failure, Respiratory Insufficiency
Keywords
High flow nasal cannula, Nasal high flow, Oxygen close-loop, Hypoxemia, Hyperoxemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen close-loop
Arm Type
Experimental
Arm Description
Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.
Arm Title
Manual FiO2 adjustment
Arm Type
Active Comparator
Arm Description
Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.
Intervention Type
Device
Intervention Name(s)
Oxygen close-loop
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
No intervention
Intervention Description
Manual FiO2 adjustment according to SpO2 values
Primary Outcome Measure Information:
Title
Percentage of time spent in optimal SpO2 range
Description
The optimal SpO2 range will be defined according to the SpO2 targets determined by the clinician.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Percentage of time spent in sub-optimal SpO2 range
Description
SpO2 values outside the optimal range but still within an acceptable limit (2-3 percent above and below the optimal range)
Time Frame
4 hours
Title
Percentage of time spent out of range
Description
Above or below the suboptimal limits specified at the begginning of the study
Time Frame
4 hours
Title
Percentage of time with SpO2 signal available
Description
Time with SpO2 signal available
Time Frame
4 hours
Title
Mean SpO2/FiO2
Description
Mean oxygenation value
Time Frame
4 hours
Title
ROX index
Description
Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate
Time Frame
4 hours
Title
Percentage of time with SpO2 below 88 and 85 percent
Description
Duration of time with SpO2 <85 percent and <88 percent, respectively
Time Frame
4 hours
Title
Number of events with SpO2 below 88 and 85 percent
Description
Frequency of SpO2 decreases <85 percent and <88 percent, respectively
Time Frame
4 hours
Title
Mean FiO2
Description
Mean fraction of inspired oxygen
Time Frame
4 hours
Title
Percentage of time with FiO2 below 40 percent and above 60%
Description
Percentage of time that FiO2 is <40 percent and >60 percent, respectively
Time Frame
4 hours
Title
Number of manual adjustments
Description
Frequency of manual adjustments of FiO2
Time Frame
4 hours
Title
Number of alarms
Description
Frequency of alarms
Time Frame
4 hours
Title
Patient comfort
Description
Comfort score by visual analogic scale (from 0 to 10)
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28729473
Citation
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.
Results Reference
background
PubMed Identifier
25855899
Citation
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.
Results Reference
background
PubMed Identifier
28679200
Citation
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.
Results Reference
background
PubMed Identifier
35422002
Citation
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.
Results Reference
derived

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Closed-loop Oxygen Control for High Flow Nasal Therapy

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