Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy (POSDOT)

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

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

Study Overview

• Status: Terminated
• Conditions: Critical Illness
• Intervention / Treatment: Other: SpO2 directed oxygen therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 1706
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University
    • Xinyang, Henan, China, 464000
      • Department of critical care medicine，Xinyang Central Hospital
    • Zhengzhou, Henan, China, 450000
      • Department of critical care medicine, Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 450000
      • Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450007
      • Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Department of critical care medicine, Renmin Hospital of Shiyan City
    • Shiyan, Hubei, China, 442000
      • Department of critical care medicine, Taihe Hospital
    • Wuhan, Hubei, China, 430022
      • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430000
      • Department of critical care medicine, The Central Hospital of Wuhan
    • Wuhan, Hubei, China, 430060
      • Department of critical care medicine，Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430079
      • Intensive Care Unit, Hubei Cancer Hospital
    • Xiangyang, Hubei, China, 441000
      • Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine
    • Xiangyang, Hubei, China, 441021
      • Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low SpO2 group; SpO2 90-95%, with FiO2 as low as possible.	Other: SpO2 directed oxygen therapy; Oxygen therapy was administered to achieve targeted SpO2.
Active Comparator: High SpO2 group; SpO2 96-100%, with FiO2 no lower than 30%.	Other: SpO2 directed oxygen therapy; Oxygen therapy was administered to achieve targeted SpO2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	Death within 28 days after inclusion	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ventilator-free time	Hours free from ventilator	14 days
RRT-free time	Hours free from renal replacment therapy	14 days

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Collaborators: Wu Jieping Medical Foundation
• Investigators: Study Director: Shiying Yuan, MD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 29, 2022

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimated): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: WuhanUHICU201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No