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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

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:

  1. Faster re-adjustment to baseline-FiO2 (baseline FiO2: mean FiO2 during the previous 5min)
  2. Delayed reduction of FiO2 below baseline FiO2
  3. 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.

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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


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.




Primary Outcome Measures :
  1. 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 :
  1. 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 .

  2. Proportion of Time with SpO2 below target range [ Time Frame: 30 hours ]
    Comparison of proportion of time with SpO2 below target range.

  3. Proportion of Time with Hypoxia [ Time Frame: 30 hours ]
    Comparison of proportion of time with SpO2 below 80%.

  4. 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.

  5. 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.

  6. Severe hypoxemic episodes [ Time Frame: 30 hours ]
    Rate of episodes with SpO2 <80% for at least 60seconds


Other Outcome Measures:
  1. Staff workload [ Time Frame: 30 hours ]
    number of manual adjustments of inspired oxygen per time

  2. 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.



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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

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