NCT04965844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

December 9, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

May 4, 2021

Last Update Submit

November 26, 2021

Conditions

High Flow Nasal CannulaOxygen TherapyHypoxemiaHyperoxemiaAcute Respiratory FailureRespiratory Insufficiency

Keywords

High flow nasal cannulaNasal high flowOxygen close-loopHypoxemiaHyperoxemia

Outcome Measures

Primary Outcomes (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.

    4 hours

Secondary Outcomes (12)

  • Percentage of time spent in sub-optimal SpO2 range

    4 hours

  • Percentage of time spent out of range

    4 hours

  • Percentage of time with SpO2 signal available

    4 hours

  • Mean SpO2/FiO2

    4 hours

  • ROX index

    4 hours

  • +7 more secondary outcomes

Study Arms (2)

Oxygen close-loop

EXPERIMENTAL

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

Device: Oxygen close-loop

Manual FiO2 adjustment

ACTIVE COMPARATOR

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

Device: No intervention

Interventions

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.

Oxygen close-loop
No interventionDEVICE

Manual FiO2 adjustment according to SpO2 values

Manual FiO2 adjustment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (4)

  • 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.

    PMID: 28729473BACKGROUND

  • 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.

    PMID: 25855899BACKGROUND

  • 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.

    PMID: 28679200BACKGROUND

  • 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.

    PMID: 35422002DERIVED

MeSH Terms

Conditions

HypoxiaRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

July 16, 2021

Study Start

April 27, 2021

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

December 9, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)