Back to resultsHigh-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
Primary Purpose
Blunt Thoracic Injury, Lung Ultrasound Score
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high-flow nasal cannula
Conventional oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Blunt Thoracic Injury
Eligibility Criteria
Inclusion Criteria:
- The trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (AIS) chest score ≥3) admitted to the ICU
Exclusion Criteria:
- had intubation and used the mechanical ventilation within 2 hours
- had the emergency surgerys within 2 hours
- patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax
- the Glasgow Coma Scale <8
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
conventional oxygen therapy
High-flow Nasal Cannula Oxygen Therapy
Arm Description
oxygen was delivered by a nasal cannula or nonrebreather mask
High-flow Nasal Cannula Oxygen Therapy
Outcomes
Primary Outcome Measures
compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
High-flow nasal cannula could reduce the intube rate of patients with blunt thoracic injury,and improve the the lung aeration for patients with thoracic injury
Secondary Outcome Measures
number of days in ICU
High-flow nasal cannula could reduce the number of days for the patients treatments in ICU
Full Information
NCT ID
NCT03430258
First Posted
January 4, 2018
Last Updated
February 5, 2018
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03430258
Brief Title
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
Official Title
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 30, 2019 (Anticipated)
Study Completion Date
March 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
Detailed Description
This prospective randomized controlled study was conducted in the emergency intensive care units (EICU) of the second affiliated hospital Zhejiang university school of medicine, a large tertiary university hospital in HangZhou, China.The aim of this randomized study was to compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Thoracic Injury, Lung Ultrasound Score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional oxygen therapy
Arm Type
Placebo Comparator
Arm Description
oxygen was delivered by a nasal cannula or nonrebreather mask
Arm Title
High-flow Nasal Cannula Oxygen Therapy
Arm Type
Active Comparator
Arm Description
High-flow Nasal Cannula Oxygen Therapy
Intervention Type
Device
Intervention Name(s)
high-flow nasal cannula
Intervention Description
high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier
Intervention Type
Device
Intervention Name(s)
Conventional oxygen therapy
Intervention Description
Conventional oxygen therapy
Primary Outcome Measure Information:
Title
compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
Description
High-flow nasal cannula could reduce the intube rate of patients with blunt thoracic injury,and improve the the lung aeration for patients with thoracic injury
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
number of days in ICU
Description
High-flow nasal cannula could reduce the number of days for the patients treatments in ICU
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- The trauma registry was used to identify patients with moderate to severe blunt thoracic injury (abbreviated injury scale (AIS) chest score ≥3) admitted to the ICU
Exclusion Criteria:
had intubation and used the mechanical ventilation within 2 hours
had the emergency surgerys within 2 hours
patients can not accessed by transthoracic lung ultrasound because of the sever aerodermectasia or pneumothorax
the Glasgow Coma Scale <8
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
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