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Automatic Oxygen Control (SPOC) in Preterm Infants

NCT03785899 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-01-04

No results posted yet for this study

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.

Conditions

  • Infantile Respiratory Distress Syndrome
  • Ventilator Lung; Newborn

Interventions

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.

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.

Sponsors & Collaborators

  • Fritz Stephan GmbH

    collaborator UNKNOWN

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Christoph E Schwarz, MD · University of Tubingen, University Hospital, Dept. Neonatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2019-08-01
Completion
2020-08-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785899 on ClinicalTrials.gov