Ventilator Lung; Newborn Clinical Trial
— CLAC-4Official title:
Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants: a Randomized Controlled Trial of a Revised Algorithm
NCT number | NCT03163108 |
Other study ID # | CLAC-4 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2017 |
Est. completion date | January 12, 2018 |
Verified date | January 2017 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Johannes Gutenberg University Mainz | Mainz | |
Germany | University of Tubingen | Tubingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Heinen und Löwenstein GmbH & Co. KG, Johannes Gutenberg University Mainz |
Germany,
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 |
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