Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-30 @ 8:44 PM
Study NCT ID:
NCT02999932
Status:
TERMINATED
Last Update Posted:
2023-07-11
First Post:
2016-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSDOT
Brief Summary:
Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs.
Detailed Description:
In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial hyperoxia following resuscitation from cardiac arrest were associated with increased in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.
Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%), conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2 of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and led to an unplanned interim analysis. In this larger multicenter trial, investigators hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the 28-day mortality in patients staying longer than 72 hours in ICUs.
Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%), conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2 of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and led to an unplanned interim analysis. In this larger multicenter trial, investigators hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the 28-day mortality in patients staying longer than 72 hours in ICUs.
Study Oversight
Has Oversight DMC:
False
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?: