Automatic Oxygen Control (SPOC) in Preterm Infants (optimalSPOC)

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ClinicalTrials.gov Identifier: NCT03785899

Recruitment Status : Unknown

Verified August 2018 by University Hospital Tuebingen.
Recruitment status was: Recruiting

First Posted : December 24, 2018

Last Update Posted : January 4, 2019

Sponsor:

Collaborator:

Fritz Stephan GmbH

Information provided by (Responsible Party):

University Hospital Tuebingen

Study Description

Brief Summary:

Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by automatic control (SPOC) with "old"-algorithm and RMC supported by CLAC with "new"-algorithm.

The first primary hypothesis is, that the use of the "new" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the new algorithm results in more time within SpO2 target range compared to SPOCold.

The second primary hypothesis is, that the use of 2 seconds averaging time of the SpO2 Signal results in more time within arterial oxygen saturation (SpO2) target range compared to the use of 8 seconds averaging interval of the SpO2 signal.

Condition or disease	Intervention/treatment	Phase
Infantile Respiratory Distress Syndrome Ventilator Lung; Newborn	Device: SPOCnew Device: 8s SpO2 averaging Device: SPOCold Device: 2s SpO2 averaging	Not Applicable

Detailed Description:

BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (SPOC) of the FiO2. The objective of this study is to test a revised, "new" algorithm with 3 adaptions against the former "old" algorithm and against RMC. The 3 adaptions are:

Faster re-adjustment to baseline-FiO2 (baseline FiO2: mean FiO2 during the previous 5min)
Delayed reduction of FiO2 below baseline FiO2
Maximum FiO2 adjustable by user

The first primary hypothesis is, that the application of SPOCnew in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the revised algorithm is more effective as the old algorithm to maintain the SpO2 in the target range.

The second primary hypothesis is, that the shortening of averaging time used for the SpO2 Signal from 8 seconds to 2 seconds results in more time within SpO2 target range for both, SPOCnew and SPOCold.

Further hypotheses for exploratory testing are, that the SPOC new algorithm will achieve a lower proportion of time with SpO2 above and below the target range, hyper- and hypoxia and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with SPOCold and RMC. Reduction of staff workload (estimated by number of manual adjustments per hour) by SPOC. Validation of a clinical scoring tool to monitor severity of apnea of prematurity.

STUDY DESIGN The Study is designed as a single-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (FiO2 above 0.21). Within a 30-hour period the investigators will compare 6 hours of RMC with 12-hour periods of RMC supported by SPOCnew algorithm or SPOCold algorithm, respectively. During intervals with SPOC control the SpO2 Signal averaging time will be 2 second or 8seconds , respectively, for 6 hours each.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal
Actual Study Start Date :	August 3, 2018
Estimated Primary Completion Date :	August 1, 2019
Estimated Study Completion Date :	August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome Bronchopulmonary Dysplasia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: RMC only routine manual control (RMC) of the fraction of inspired oxygen (FIO2)
Experimental: SPOCnew and 2s SpO2 averaging routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s.	Device: SPOCnew SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised "new" algorithm is turned on. Device: 2s SpO2 averaging The arterial saturation (SPO2) will be averaged over 2s.
Experimental: SPOCnew and 8s SpO2 averaging routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s.	Device: SPOCnew SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised "new" algorithm is turned on. Device: 8s SpO2 averaging The arterial saturation (SPO2) will be averaged over 8s.
Active Comparator: SPOCold and 2s SpO2 averaging routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s.	Device: SPOCold SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former "old" algorithm is turned on. Device: 2s SpO2 averaging The arterial saturation (SPO2) will be averaged over 2s.
Active Comparator: SPOCold and 8s SpO2 averaging routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s.	Device: 8s SpO2 averaging The arterial saturation (SPO2) will be averaged over 8s. Device: SPOCold SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former "old" algorithm is turned on.

Outcome Measures

Primary Outcome Measures :

Proportion of time with SpO2 within target range [ Time Frame: 30 hours ]
Comparison of proportion of time with SpO2 within target range and time above target range if no supplemental oxygen was administered at that time and within the preceding 30sec between the five treatment modalities

Secondary Outcome Measures :

Proportion of Time with SpO2 above target range [ Time Frame: 30 hours ]
Comparison of proportion of time with SpO2 above target range if supplemental oxygen was administered at that time or within the preceding 30sec .
Proportion of Time with SpO2 below target range [ Time Frame: 30 hours ]
Comparison of proportion of time with SpO2 below target range.
Proportion of Time with Hypoxia [ Time Frame: 30 hours ]
Comparison of proportion of time with SpO2 below 80%.
Proportion of Time with Hyperoxia [ Time Frame: 30 hours ]
Comparison of proportion of time with SpO2 above 97% if supplemental oxygen was administered at that time or at anytime during the previous 30 seconds.
Stability of cerebral oxygenation [ Time Frame: 30 hours ]
"Area under the curve" of cerebral tissue saturation or fraction of tissue oxygen extraction outside of the infants Median +- 5% or outside of the "safe" interval of 55-80% rcStO2.
Severe hypoxemic episodes [ Time Frame: 30 hours ]
Rate of episodes with SpO2 <80% for at least 60seconds

Other Outcome Measures:

Staff workload [ Time Frame: 30 hours ]
number of manual adjustments of inspired oxygen per time
Validation of clinical Apnea Score [ Time Frame: 30 hours ]
Validation of a modified Apnea Score monitored by clinical staff by correlation between Score and other secondary outcomes. The modified Apnoea Score aims to quantify the burden from apnoea-bradycardia-syndrome by assigning 1-2-4 or 8 points according to event severity. Points are summed up during each treatment period in this study.

Eligibility Criteria

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Ages Eligible for Study:	up to 34 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

gestational age at birth <34+1/7weeks and
invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and
Fraction of inspired oxygen above 0.21 before inclusion and
more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion and
parental written informed consent

Exclusion Criteria (any of the following):

congenital pulmonary anomalies
congenital heart defects influencing SpO2 (i.e. cyanotic heart defects)
right-to -left shunt through a PDA
Severe neonatal complications during study period (sepsis, necrotising enterocolitis)
diaphragmatic hernia or other diaphragmatic disorders

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785899

Contacts

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Contact: Christoph E Schwarz, MD	+49707129-0 ext 84742	c.schwarz@med.uni-tuebingen.de
Contact: Axel R Franz, MD	+49707129-0 ext 83791	axel.franz@med.uni-tuebingen.de

Locations

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Germany
Department of Neonatology, University Children's Hospital	Recruiting
Tübingen, Germany, 72076
Contact: Christoph E Schwarz, MD +49707129-0 ext 80895 c.schwarz@med.uni-tuebingen.de
Contact: Axel R Franz, MD +49707129-0 ext 83791 axel.franz@med.uni-tuebingen.de

Sponsors and Collaborators

University Hospital Tuebingen

Fritz Stephan GmbH

Investigators

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Principal Investigator:	Christoph E Schwarz, MD	University of Tubingen, University Hospital, Dept. Neonatology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O'Sullivan MP, Poets CF, Franz AR. Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Nov 24. pii: fetalneonatal-2021-322096. doi: 10.1136/archdischild-2021-322096. [Epub ahead of print]

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Responsible Party:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT03785899
Other Study ID Numbers:	optimalSPOC
First Posted:	December 24, 2018 Key Record Dates
Last Update Posted:	January 4, 2019
Last Verified:	August 2018

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Bronchopulmonary Dysplasia Hyaline Membrane Disease Lung Diseases Respiratory Tract Diseases	Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Ventilator-Induced Lung Injury Lung Injury

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