Automated Titration for Home Oxygen Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

AutoO2: Automated Titration of Oxygen (Auto-O2) using a closed-loop system in which the oxygen flow to the participant is continuously adjusted on the basis of pulse oximetry signals to maintain a target range of oxygen saturation to meet the participant's immediate needs.

FixedO2: Fixed flow oxygen delivery administered using manual flow meters according to standard clinical procedures.

Study summary

Patients with chronic respiratory disease may be prescribed oxygen therapy. Currently, the dose of oxygen flow is fixed (FixedO2) depending on activity level i.e. rest, physical activity and sleep. Automated Titration of Oxygen (AutoO2) is a closed-loop system in which the oxygen flow to the patient is continuously machine adjusted to meet the patient's immediate needs on the basis of signals from pulse oximetry (SpO2). The purpose of this study is to examine if automated oxygen control based on pulse oximetry provided to participants is superior to prescribed fixed oxygen flow in keeping SpO2 within the intended target interval of 92 to 96% arterial oxygen saturation.

Eligibility

Primary outcome measure(s)

• Daily time spent normoxic as defined by an arterial oxygen saturation measured by pulse oximetry (SpO2), between 92 to 96%, will be expressed a function of total time recorded SpO2. — 24 hour
  SpO2 will be recorded throughout the day (24 hours). The primary outcome measure equals the daily time with 92%≥SpO2≤ 96% (numerator) divided by the total daily time of measured SpO2 (denominator).

Trial sites (1)

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