Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy

Critical Illness Clinical Trial

— POSDOT  

Official title:

Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02999932
• Other study ID #: WuhanUHICU201701
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 29, 2022

Study information

• Verified date: September 2022
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the mortality in patients staying longer than 72 hours in ICUs.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1706
• Est. completion date: May 29, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years or older and admitted into ICU, with expected stay in ICU more than 72 hours or longer.

Exclusion Criteria:

• under 18 years old, expected stay in ICU less than 72 hours, unconsented inclusion, ICU readmission, patients with acute exacerbation of chronic obstruction disease, patients with severe acute respiratory distress syndrome (defined as PaO2/FiO2 = 100mmHg and PEEP =10cmH2O), decision to withhold life-sustaining treatment, physician forgetting to screen during 12 hours after admission, pregnancy, patients with acute myocardial infarction, paraquat poisoning and patients on extracorporeal membrane oxygenation (ECMO) or planned to be on ECMO.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• SpO2 directed oxygen therapy
Oxygen therapy was administered to achieve targeted SpO2.

Locations

Country	Name	City	State
China	Department of critical care medicine,Luoyang Central Hospital Affiliated to ZhengZhou University	Luoyang	Henan
China	Department of critical care medicine, Renmin Hospital of Shiyan City	Shiyan	Hubei
China	Department of critical care medicine, Taihe Hospital	Shiyan	Hubei
China	Department of critical care medicine, The Central Hospital of Wuhan	Wuhan	Hubei
China	Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Department of critical care medicine,Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Intensive Care Unit, Hubei Cancer Hospital	Wuhan	Hubei
China	Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science	Xiangyang	Hubei
China	Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine	Xiangyang	Hubei
China	Department of critical care medicine,Xinyang Central Hospital	Xinyang	Henan
China	Department of critical care medicine, Henan Provincial People's Hospital	Zhengzhou	Henan
China	Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Department of critical care medicine,Zhengzhou Central Hospital Affiliated to Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	Death within 28 days after inclusion	28 days
Secondary	ventilator-free time	Hours free from ventilator	14 days
Secondary	RRT-free time	Hours free from renal replacment therapy	14 days