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

NCT03163108 | Completed

• 1 other identifier: CLAC-4
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Infant Respiratory Distress Syndrome; Ventilator Lung; Newborn

Keywords

controller; hyperoxia; hypoxia; ventilation; cerebral oxygenation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Duration of hyperoxaemia

  16 hours

• Duration of hypoxaemia

  16 hours

• Duration of "overshoot" hyperoxaemia

  16 hours

• Number of "overshoot" hyperoxaemia

  16 hours

• Stability of cerebral oxygenation

  24 hours

Other Outcomes (1)

• Staff workload

  24 hours

Study Arms (3)

RMC only

NO INTERVENTION

routine manual control (RMC) of the fraction of inspired oxygen (FIO2)

CLAC slow

ACTIVE COMPARATOR

routine manual control (RMC) + Closed-loop automatic oxygen control (CLAC) with 180sec WAIT-Interval ("slow" algorithm) of the fraction of inspired oxygen (FIO2)

Device: Closed-loop automatic oxygen control (CLAC) slow in addition to RMC

CLAC fast

EXPERIMENTAL

routine manual control (RMC) + Closed-loop automatic oxygen control (CLAC) with 30sec WAIT-Interval ("fast" algorithm) of the fraction of inspired oxygen (FIO2)

Device: Closed-loop automatic oxygen control (CLAC) fast in addition to RMC

Interventions

Closed-loop automatic oxygen control (CLAC) fast in addition to RMC DEVICE

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).

CLAC fast

Closed-loop automatic oxygen control (CLAC) slow in addition to RMC DEVICE

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).

CLAC slow

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• gestational age at birth \<34+1/7weeks
• invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support
• parental written informed consent

You may not qualify if:

• congenital pulmonary anomalies
• diaphragmatic hernia or other diaphragmatic disorders

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Johannes Gutenberg University Mainz: collaborator
• Heinen und Löwenstein GmbH & Co. KG: collaborator

Study Sites (2)

Johannes Gutenberg University Mainz

Mainz, Germany

Location

University of Tubingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Schwarz CE, Kidszun A, Bieder NS, Franz AR, Konig J, Mildenberger E, Poets CF, Seyfang A, Urschitz MS. Is faster better? A randomised crossover study comparing algorithms for closed-loop automatic oxygen control. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):369-374. doi: 10.1136/archdischild-2019-317029. Epub 2019 Sep 16.

  PMID: 31527093 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis; Bronchopulmonary Dysplasia; Hyperoxia; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Pathologic Processes

Study Officials

• Axel R Franz, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: May 22, 2017
• Study Start: March 15, 2017
• Primary Completion: December 18, 2017
• Study Completion: January 12, 2018
• Last Updated: May 15, 2018

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)