Weaning Oxygen Therapy With Model-based Adaptive Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Duration of hyperoxia
Study Overview
Brief Summary
The study is designed to evaluate the feasibility, safety and clinical utility of using an adaptive model to wean oxygen by computer assistance. Investigators hypothesize that weaning oxygen using this model will decrease duration of exposure to hyperoxia, decrease duration of exposure to hypoxia, decrease exposure to increased oxygen requirement, and decrease the number of manual fraction of inspired oxygen (FiO2) adjustments as compared to manual weaning of oxygen therapy.
Detailed Description
Investigators will perform a feasibility study followed by a randomized, controlled study on critically ill neonatal and pediatric patients on oxygen therapy.
Investigators will use a model-based adaptive control architecture to regulate FiO2 settings. A major advantage of using an "adaptive" control system is that the response of the patient to previous FiO2 settings are used to recompute the most appropriate FiO2 setting in fixed time intervals. As a result of this iterative and self-correcting process, the FiO2 value converges to the most appropriate value over a period of time.
Study Population:
Children <18 years of age admitted to the pediatric intensive care unit requiring oxygen therapy.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •0 to 2 years of age
- •Admission to pediatric intensive care unit
- •Oxygen therapy with FiO2 >0.21 via high flow nasal cannula >4 litres per minute (LPM) oxygen or via mechanical ventilation
Exclusion Criteria
- •No supplemental oxygen requirement or less than 4 LPM oxygen by nasal cannula
- •Congenital cardiac disease
- •Pulmonary hypertension
- •Hemodynamic instability requiring intervention
- •Respiratory status deemed too tenuous for weaning by attending physician
- •Ward of the state
Outcomes
Primary Outcomes
Duration of hyperoxia
Time Frame: Entire study (anticipated as 2 years).
Duration of time patients exposed to hyperoxia
Secondary Outcomes
- Oxygen saturation in target range(Entire study (anticipated as 2 years).)
- Increased oxygen requirement(Entire study (anticipated as 2 years).)
- Time of increased oxygen requirement(Entire study (anticipated as 2 years).)
- Hypoxia incidence(Entire study (anticipated as 2 years).)
- Duration of hypoxia(Entire study (anticipated as 2 years).)
- Manual adjustments(Entire study (anticipated as 2 years).)
Investigators
Azadeh Fayazi
Clinical Assistant Professor
Stanford University