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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04965844
Other study ID # PR(AG)539/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2021
Est. completion date August 10, 2021

Study information

Verified date October 2021
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date August 10, 2021
Est. primary completion date August 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
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

Locations

Country Name City State
Spain Hospital Universitari Vall d'Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. Review. — View 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). pii: 1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) 4 hours
Secondary Percentage of time spent out of range Above or below the suboptimal limits specified at the begginning of the study 4 hours
Secondary Percentage of time with SpO2 signal available Time with SpO2 signal available 4 hours
Secondary Mean SpO2/FiO2 Mean oxygenation value 4 hours
Secondary ROX index Is a predictor of HFNT success/failure defined as (SpO2/FiO2)/respiratory rate 4 hours
Secondary Percentage of time with SpO2 below 88 and 85 percent Duration of time with SpO2 <85 percent and <88 percent, respectively 4 hours
Secondary Number of events with SpO2 below 88 and 85 percent Frequency of SpO2 decreases <85 percent and <88 percent, respectively 4 hours
Secondary Mean FiO2 Mean fraction of inspired oxygen 4 hours
Secondary Percentage of time with FiO2 below 40 percent and above 60% Percentage of time that FiO2 is <40 percent and >60 percent, respectively 4 hours
Secondary Number of manual adjustments Frequency of manual adjustments of FiO2 4 hours
Secondary Number of alarms Frequency of alarms 4 hours
Secondary Patient comfort Comfort score by visual analogic scale (from 0 to 10) 4 hours
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