Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153485
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-02
Brief Title:
Automated Titration for Home Oxygen Therapy
Sponsor:
West Park Healthcare Centre
Organization:
West Park Healthcare Centre
Study Overview
Official Title:
Effectiveness of Automated Titration Designed for Home Oxygen Therapy
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with chronic respiratory disease may be prescribed oxygen therapy Currently the dose of oxygen flow is fixed FixedO2 depending on activity level ie 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 patients 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
Detailed Description:
Patients with chronic respiratory disease may be prescribed oxygen therapy Currently the dose of oxygen flow is fixed FixedO2 The fixed flow is adjusted by category of activity rest physical activity and sleep hereafter known as their state The flow remains the same throughout each state and day-to-day regardless of the patients disease status 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 patients immediate needs on the basis of signals from pulse oximetry SpO2 The auto-titration system used in this study is intended for home use by patients for whom home oxygen has been prescribed It includes the central monitoring of automatic titration Before its use at home it must demonstrate its abilities consistently in a supervised free living environment In this crossover trial patients already using supplemental oxygen and admitted to one of West Park Healthcare Centres in-patient respiratory programs are exposed to alternating consecutive weeks of 1 usual fixed dose oxygen or 2 automated oxygen titration 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 To determine whether AutoO2 provides a more precise method of supplemental oxygen delivery manifested by greater amount of time within a targeted oxygen saturation t92-96 compared to fixed flow oxygen therapy in individuals with chronic respiratory disease Participants will be randomised 11 to start with FixedO2 or AutoO2 using a computer generated block randomisation scheme They will then alternate between conditions weekly over 4 weeks Participants will use their usual oxygen delivery method and equipment The AutoO2 will be inserted in-line as part of the participants usual fixed flow system All patient activities associated with their participation in the pulmonary rehabilitation program are unchanged We will use continuous activity monitoring to categorize activity state ierest physical activity or sleep Cardiac pulse from the oximeter will be used to corroborate the activity state We will record oxygen flow from the source to the participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None