NCT02999932

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,706

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
2.4 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2022

Completed
Last Updated

July 11, 2023

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

December 14, 2016

Last Update Submit

July 8, 2023

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    Death within 28 days after inclusion

    28 days

Secondary Outcomes (2)

  • ventilator-free time

    14 days

  • RRT-free time

    14 days

Study Arms (2)

Low SpO2 group

EXPERIMENTAL

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

Other: SpO2 directed oxygen therapy

High SpO2 group

ACTIVE COMPARATOR

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

Other: SpO2 directed oxygen therapy

Interventions

SpO2 directed oxygen therapyOTHER

Oxygen therapy was administered to achieve targeted SpO2.

High SpO2 groupLow SpO2 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University

Luoyang, Henan, 471000, China

Location

Department of critical care medicine，Xinyang Central Hospital

Xinyang, Henan, 464000, China

Location

Department of critical care medicine, Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450007, China

Location

Department of critical care medicine, Renmin Hospital of Shiyan City

Shiyan, Hubei, 442000, China

Location

Department of critical care medicine, Taihe Hospital

Shiyan, Hubei, 442000, China

Location

Department of critical care medicine, The Central Hospital of Wuhan

Wuhan, Hubei, 430000, China

Location

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Department of critical care medicine，Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Intensive Care Unit, Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine

Xiangyang, Hubei, 441000, China

Location

Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science

Xiangyang, Hubei, 441021, China

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shiying Yuan, MD

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 14, 2016

First Posted

December 21, 2016

Study Start

May 1, 2019

Primary Completion

May 1, 2022

Study Completion

May 29, 2022

Last Updated

July 11, 2023

Record last verified: 2022-09

Locations

CN(13)