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Comparison of Oxygen Controllers in Preterm InfanTs (COCkPIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877198
Recruitment Status : Terminated (As a result of a slower inclusion rate than expected, competence of medical staff to work with the AVEA ventilator could no longer be guaranteed.)
First Posted : March 15, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
University of Tasmania
Information provided by (Responsible Party):
PasABte, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE February 19, 2019
Actual Primary Completion Date February 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
Proportion of time with SpO2 spent within set target range [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
Total time SpO2 is within the set target range (91-95%) including time spent above target range when in room air (set FiO2 < 0.22)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Proportion of time with SpO2 spent above target range (SpO2 > 95%) [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
  • Proportion of time with SpO2 spent below target range (SpO2 < 91%) [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
  • Coefficient of SpO2 variation [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
  • Time in hypoxemic SpO2 ranges [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    Time in SpO2 range 85-90%, 80-84% and <80%
  • Time in hyperoxemic SpO2 ranges [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    Time in SpO2 range 96-98% and >98%
  • Frequency of episodes of hypoxemia [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    Episodes in hypoxemia with SpO2 < 85% for ≥ 30 seconds, for ≥ 60 seconds and hypoxemia < 80% for ≥ 30 seconds and ≥ 60 seconds
  • Frequency of episodes of hyperoxemia [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    Episodes in hyperoxemia with SpO2 ≥ 97% for ≥ 30 seconds, for ≥ 60 seconds and hyperoxemia ≥ 99% for ≥ 30 seconds and ≥ 60 seconds
  • Frequency of episodes of bradycardia [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    Episodes where the heart rate < 100 beats per minute for ≥ 10 seconds
  • Frequency of FiO2 adjustments during automated control [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
    FiO2 adjustments as made by the controller and by bedside staff as manual over-rides by the bedside staff as well
  • Average oxygen exposure [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
  • Coefficient of variation of FiO2 [ Time Frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded. ]
  • Effects on nursing workload in relation to FiO2 adjustment [ Time Frame: From randomization until study completion. (maximum of 50 hours) Manual adjustments during wash-out periods will be excluded. ]
    Number of manual FiO2 adjustments and as the effect on workload measured by a translated questionnaire adapted from the NASA TLX questionnaire, using a visual rating scale
  • Confidence of the bedside staff in the automated control system [ Time Frame: From randomization until study completion. (maximum of 50 hours) ]
    Measured at the end of each nursing shift by a subset of questions out of the System Trust Scale (Jian et al. 2000) questionnaire. All questions are answered on a 1 (not at all) to 7 (extremely) scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Oxygen Controllers in Preterm InfanTs
Official Title  ICMJE A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
Brief Summary Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.
Detailed Description

Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. The currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear.

This randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. The primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. This is excluding a 1-hour wash-out period after a change in ventilator.

Eligible infants are randomized to start with either the Oxygenie algorithm or CLiO2 algorithm and will switch to the other study arm after 24 hours of measurement.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome assessor/investigator will be blinded for treatment allocation
Primary Purpose: Treatment
Condition  ICMJE
  • Premature Infant
  • Respiratory Insufficiency
  • Hypoxia
  • Hyperoxia
Intervention  ICMJE
  • Device: Automated oxygen control by the CLiO2 algorithm
    Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period
    Other Name: AVEA CLiO2
  • Device: Automated oxygen control by the Oxygenie algorithm
    Automated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period.
    Other Name: SLE Oxygenie
Study Arms  ICMJE
  • Experimental: CLiO2
    Automated oxygen control by the CLiO2 algorithm
    Intervention: Device: Automated oxygen control by the CLiO2 algorithm
  • Experimental: Oxygenie
    Automated oxygen control by the Oxygenie algorithm
    Intervention: Device: Automated oxygen control by the Oxygenie algorithm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 5, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
50
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date February 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
  • Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
  • Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
  • Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
  • Written informed parental consent must be present.

Exclusion Criteria:

  • Major congenital anomalies
  • Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
  • If the attending physician considers the infant not stable enough for a switch to another ventilator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877198
Other Study ID Numbers  ICMJE COCkPIT
NL66058.000.18 ( Other Identifier: Dutch Central Committee on Research Involving Human Subjects )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party PasABte, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE University of Tasmania
Investigators  ICMJE
Principal Investigator: Arjan B te Pas, Prof Leiden University Medical Center
Principal Investigator: Peter A Dargaville, Prof University of Tasmania
PRS Account Leiden University Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP