Computer-assisted Oxygen Therapy Weaning in Critically Ill Children

NCT03550469 | Terminated

• 1 other identifier: IRB-42274
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia; Hypoxia

Keywords

hyperoxia; hypoxia

Outcome Measures

Primary Outcomes (1)

• Duration of hyperoxia

  Duration of time patients exposed to hyperoxia

  Entire study (anticipated as 2 years).

Secondary Outcomes (6)

• Hypoxia incidence

  Entire study (anticipated as 2 years).

• Duration of hypoxia

  Entire study (anticipated as 2 years).

• Oxygen saturation in target range

  Entire study (anticipated as 2 years).

• Increased oxygen requirement

  Entire study (anticipated as 2 years).

• Manual adjustments

  Entire study (anticipated as 2 years).

Study Arms (2)

Computer-assisted Oxygen Weaning

EXPERIMENTAL

A computer with an adaptive model algorithm will guide oxygen weaning.

Device: Computer-assisted Oxygen Weaning

Manual Oxygen Weaning

NO INTERVENTION

Oxygen weaning will be done by staff manually.

Interventions

Computer-assisted Oxygen Weaning DEVICE

Oxygen therapy weaning will be guided by a model-based computer algorithm. The computer will detect patients' oxygen saturation and made recommendations for oxygen weaning. A clinical at the bedside will make the adjustments in oxygen therapy if appropriate.

Computer-assisted Oxygen Weaning

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Childrens Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Hyperoxia; Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Azadeh Fayazi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The intervention group will have oxygen therapy adjustment by computer-assistance. The control group will have adjustments by staff.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 8, 2018
• Study Start: November 2, 2018
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)