Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2021-04-27
2021-08-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Oxygen close-loop
Four hours period where the fraction of inspired oxygen delivered will be automatically titrated based on SpO2 values.
Oxygen close-loop
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.
Manual FiO2 adjustment
Four hours period where the fraction of inspired oxygen delivered will be manually adjusted by the healthcare personnel based on SpO2 values.
No intervention
Manual FiO2 adjustment according to SpO2 values
Interventions
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Oxygen close-loop
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
Manual FiO2 adjustment according to SpO2 values
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Locations
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Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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PR(AG)539/2020
Identifier Type: -
Identifier Source: org_study_id