Extubation Readiness Study in Very Low Birthweight Infants
NCT ID: NCT01471431
Last Updated: 2016-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
81 participants
INTERVENTIONAL
2011-08-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Spontaneous breathing trial
The spontaneous breathing trial will determine the extubation readiness of the subject.
spontaneous breathing trial
The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40).
During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia \<100 for \>15 seconds or oxygen saturation by pulse oximetry \<85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met.
Usual care
Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.
No interventions assigned to this group
Interventions
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spontaneous breathing trial
The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40).
During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia \<100 for \>15 seconds or oxygen saturation by pulse oximetry \<85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met.
Eligibility Criteria
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Inclusion Criteria
* Postmenstrual age \<34 weeks
* Mechanically ventilated \>48 hours
* Never successfully extubated
Exclusion Criteria
* Known or suspected airway anomalies
* Severe congenital malformations
* Need to remain intubated for other reasons (i.e. having surgery)
* Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
48 Hours
14 Weeks
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Ann-Johanna Giaccone, MD
Role: STUDY_DIRECTOR
University of Pennsylvania
Barbara Schmidt, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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The Hospital of the University of Pennsylvania
Phialdelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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813859
Identifier Type: -
Identifier Source: org_study_id
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