Automatic Oxygen Control (SPOC) in Preterm Infants

Ventilator Lung; Newborn Clinical Trial

— optimalSPOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785899
• Other study ID #: optimalSPOC
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2018
• Source: University Hospital Tuebingen
• Contact: Christoph E Schwarz, MD
• Phone: +49707129-0
• Email: c.schwarz[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyaline Membrane Disease
• Infantile Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Ventilator Lung; Newborn

Intervention

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.
• 8s SpO2 averaging
The arterial saturation (SPO2) will be averaged over 8s.
• 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.
• 2s SpO2 averaging
The arterial saturation (SPO2) will be averaged over 2s.

Locations

Country	Name	City	State
Germany	Department of Neonatology, University Children's Hospital	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Fritz Stephan GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff workload	number of manual adjustments of inspired oxygen per time	30 hours
Other	Validation of clinical Apnea Score	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
Primary	Proportion of time with SpO2 within target range	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	Proportion of Time with SpO2 above target range	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
Secondary	Proportion of Time with SpO2 below target range	Comparison of proportion of time with SpO2 below target range.	30 hours
Secondary	Proportion of Time with Hypoxia	Comparison of proportion of time with SpO2 below 80%.	30 hours
Secondary	Proportion of Time with Hyperoxia	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
Secondary	Stability of cerebral oxygenation	"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
Secondary	Severe hypoxemic episodes	Rate of episodes with SpO2 <80% for at least 60seconds	30 hours