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

January 2, 2019 updated by: University Hospital Tuebingen

Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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.
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.

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.
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.

The arterial saturation (SPO2) will be averaged over 2s.
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.
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.

The arterial saturation (SPO2) will be averaged over 8s.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
30 hours
Proportion of Time with SpO2 below target range
Time Frame: 30 hours
Comparison of proportion of time with SpO2 below target range.
30 hours
Proportion of Time with Hypoxia
Time Frame: 30 hours
Comparison of proportion of time with SpO2 below 80%.
30 hours
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.
30 hours
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.
30 hours
Severe hypoxemic episodes
Time Frame: 30 hours
Rate of episodes with SpO2 <80% for at least 60seconds
30 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staff workload
Time Frame: 30 hours
number of manual adjustments of inspired oxygen per time
30 hours
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.
30 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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