Clinical trial NCT02999932: Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy
Official title: Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critical Illness
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2016-12-21
Enrollment: 1706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: ventilator-free time
timeFrame: 14 days
measure: RRT-free time
timeFrame: 14 days
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University
state: Henan
city: Xinyang
country: China
facility: Department of critical care medicine，Xinyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Department of critical care medicine, Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University
state: Henan
city: Shiyan
country: China
facility: Department of critical care medicine, Renmin Hospital of Shiyan City
state: Hubei
city: Shiyan
country: China
facility: Department of critical care medicine, Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Department of critical care medicine, The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Department of critical care medicine，Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Intensive Care Unit, Hubei Cancer Hospital
state: Hubei
city: Xiangyang
country: China
facility: Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine
state: Hubei
city: Xiangyang
country: China
facility: Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Shiying Yuan, MD
role: STUDY_DIRECTOR
References: