Blunt Thoracic InjuryNCT03430258
High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
A study testing high-flow nasal cannula and Conventional oxygen therapy in people with Blunt Thoracic Injury and Lung Ultrasound Score, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Thoracic Injury, Lung Ultrasound Score
- What is being tested?
- high-flow nasal cannula and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Blunt Thoracic Injury, Lung Ultrasound Score
- Being tested
- high-flow nasal cannula, Conventional oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow nasal cannulaDevice
high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier
Conventional oxygen therapyDevice
Conventional oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| conventional oxygen therapy | Placebo comparator | oxygen was delivered by a nasal cannula or nonrebreather mask Receives: Device: Conventional oxygen therapy |
| High-flow Nasal Cannula Oxygen Therapy | Active comparator | High-flow Nasal Cannula Oxygen Therapy Receives: Device: high-flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (1)
number of days in ICU
High-flow nasal cannula could reduce the number of days for the patients treatments in ICU
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Mar 2018 (estimated)
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Thoracic InjuryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430258
- Sponsor's protocol ID
- 19850703
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy With the Chest Trauma Patients
- ClinicalTrials.gov ID
- NCT03430258
- Acronym / sponsor ID
- 19850703
- Conditions
- Blunt Thoracic Injury, Lung Ultrasound Score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional oxygen therapy | Placebo comparator | Device: Conventional oxygen therapyoxygen was delivered by a nasal cannula or nonrebreather mask |
| High-flow Nasal Cannula Oxygen Therapy | Active comparator | Device: high-flow nasal cannulaHigh-flow Nasal Cannula Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-flow nasal cannulahigh flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier | Device | High-flow Nasal Cannula Oxygen Therapy |
| Conventional oxygen therapyConventional oxygen therapy | Device | conventional oxygen therapy |
Primary outcome
compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury.
Time frame: 72 hours
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
1 secondary outcome
number of days in ICU
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high-flow nasal cannula and Conventional oxygen therapy in people with Blunt Thoracic Injury and Lung Ultrasound Score, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the effectiveness of high-flow nasal cannula with conventional oxygen therapy in ICU patients with blunt thoracic injury. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.