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

Primary Purpose

Critical Illness

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SpO2 directed oxygen therapy
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low SpO2 group

High SpO2 group

Arm Description

SpO2 90-95%, with FiO2 as low as possible.

SpO2 96-100%, with FiO2 no lower than 30%.

Outcomes

Primary Outcome Measures

28-day mortality
Death within 28 days after inclusion

Secondary Outcome Measures

ventilator-free time
Hours free from ventilator
RRT-free time
Hours free from renal replacment therapy

Full Information

First Posted
December 14, 2016
Last Updated
July 8, 2023
Sponsor
Wuhan Union Hospital, China
Collaborators
Wu Jieping Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02999932
Brief Title
Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy
Acronym
POSDOT
Official Title
Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Slow inclusion
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
Collaborators
Wu Jieping Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1706 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low SpO2 group
Arm Type
Experimental
Arm Description
SpO2 90-95%, with FiO2 as low as possible.
Arm Title
High SpO2 group
Arm Type
Active Comparator
Arm Description
SpO2 96-100%, with FiO2 no lower than 30%.
Intervention Type
Other
Intervention Name(s)
SpO2 directed oxygen therapy
Intervention Description
Oxygen therapy was administered to achieve targeted SpO2.
Primary Outcome Measure Information:
Title
28-day mortality
Description
Death within 28 days after inclusion
Time Frame
28 days
Secondary Outcome Measure Information:
Title
ventilator-free time
Description
Hours free from ventilator
Time Frame
14 days
Title
RRT-free time
Description
Hours free from renal replacment therapy
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiying Yuan, MD
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Director
Facility Information:
Facility Name
Department of critical care medicine,Luoyang Central Hospital Affiliated to ZhengZhou University
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
Department of critical care medicine,Xinyang Central Hospital
City
Xinyang
State/Province
Henan
ZIP/Postal Code
464000
Country
China
Facility Name
Department of critical care medicine, Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Department of critical care medicine,Zhengzhou Central Hospital Affiliated to Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450007
Country
China
Facility Name
Department of critical care medicine, Renmin Hospital of Shiyan City
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
Department of critical care medicine, Taihe Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
Facility Name
Department of critical care medicine, The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Department of critical care medicine,Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
Intensive Care Unit, Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441000
Country
China
Facility Name
Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy

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