Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants

Ventilator Lung; Newborn Clinical Trial

— CLAC-4  

Official title:

Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants: a Randomized Controlled Trial of a Revised Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163108
• Other study ID #: CLAC-4
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: January 12, 2018

Study information

• Verified date: January 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two-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 closed-loop automatic control (CLAC) with "slow"-algorithm and RMC supported by CLAC with "fast"-algorithm.

The primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

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 (CLAC) of the FiO2 and demonstrated its safety and efficacy in a multi-center study. The objective of this study is to test a revised, "faster" algorithm with a shorter WAIT-interval of 30sec (= time between FiO2 changes) against the previously tested algorithm (WAIT of 180sec) and against RMC. The primary hypothesis is, that the application of CLAC with the "faster" algorithm 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 faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

Further hypotheses for exploratory testing are, that the "fast" algorithm will achieve a higher proportion of time with SpO2 within target range and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with the slow algorithm.

STUDY DESIGN The Study is designed as a two-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 twenty-four-hour period the investigators will compare 8 hours of RMC with 8-hour periods of RMC supported by CLAC "slow" algorithm or "fast" algorithm, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 12, 2018
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• gestational age at birth <34+1/7weeks

• invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support

• Fraction of inspired oxygen above 0.21 before inclusion

• more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion

• parental written informed consent

Exclusion Criteria:

• congenital pulmonary anomalies

• diaphragmatic hernia or other diaphragmatic disorders

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Infant Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Ventilator Lung; Newborn

Intervention

Device:
• Closed-loop automatic oxygen control (CLAC) fast in addition to RMC
Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 30s).
• Closed-loop automatic oxygen control (CLAC) slow in addition to RMC
Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 180s).

Locations

Country	Name	City	State
Germany	Johannes Gutenberg University Mainz	Mainz
Germany	University of Tubingen	Tubingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Heinen und Löwenstein GmbH & Co. KG, Johannes Gutenberg University Mainz

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	24 hours
Primary	Proportion of time with SpO2 within target range	Comparison of proportion of time with SpO2 within target range if the infant requires supplemental oxygen and time above target range if the infant requires no supplemental oxygen between CLAC-fast and RMC (superiority hypothesis).	16 hours
Primary	Proportion of Time with SpO2 within target range	Comparison of proportion of time with SpO2 within target range if the infant requires supplemental oxygen and time above target range if the infant requires no supplemental oxygen between CLAC-fast and CLAC-slow (subordinate, non inferiority hypothesis).	16 hours
Secondary	Duration of hyperoxaemia	Time with arterial oxygen saturation above 95% if the infant requires supplemental oxygen (hyperoxaemia).	16 hours
Secondary	Duration of hypoxaemia	Time with arterial oxygen saturation below 80% (hypoxaemia)	16 hours
Secondary	Duration of "overshoot" hyperoxaemia	Comparison of proportion of time with SpO2 higher than 95% after an automated increase of FiO2 between CLAC-fast and CLAC-slow.	16 hours
Secondary	Number of "overshoot" hyperoxaemia	Comparison of number of events with SpO2 higher than 95% after an automated increase of FiO2 between CLAC-fast and CLAC-slow.	16 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 "save" interval of 55-80% rcStO2.	24 hours