Chest TraumaNCT05342103
High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma
A study testing high flow oxygenation in people with Chest Trauma, run by Huda Fahmy Mahmoud, PhD at 1 site in Egypt.
Trial summary
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chest Trauma
- What is being tested?
- high flow oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 19 Jan 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Rib fractures, pulmonary contusion, and admission within 24 h of injury
- Hypoxemia (SpO2 90 % while breathing 10 l/min oxygen in the ER), or hypercapnia (PaCO2 45 mm Hg) on study entry
- respiratory rate 25/ min despite an optimized intravenous analgesia
- No indication of mechanical ventilation at the time of admission to the intensive care unit
Who cannot join
- Patients < 18 years old
- Patient already admitted to ICU on mechanical ventilation
- requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
- facial fractures or base of skull fractures
- Who did not receive a chest computed tomography (CT) scan
- Glasgow Coma Scale ≤ 12
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma: A Comparative Study
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity, especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized. In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay. Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing ARDS after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.
Read the detailed description
In the past years, High-flow nasal cannula oxygen (HFNC) has gained an important popularity among intensivest to manage patients with acute respiratory failure, filling a gap in the ventilatory support escalation between facemask oxygen and non-invasive or invasive mechanical ventilation. Interestingly, the use of HFNC was widely and rapidly adopted in ICUs.A unique feature of HFNC is its ability to comfortably deliver high flows of warmed humidified gas, 20-70 L min, with a FiO2 range of 0.21-1.0. Physiological responses to HFNC therapy include increases in airway pressure, end-expiratory lung volume (EELV), and oxygenation which are probably optimal with higher flows (60-70 L/min), while the effects on dead-space washout work of breathing, and respiratory rate may be obtained with intermediate flows (20-45 L/min).
Many studies have found that high flow nasal oxygen is much better tolerated by patients compared to non-invasive ventilation, which may improve compliance. Nevertheless, there is no clear consensus on the treatment outcomes (such as intubation rate, escalated respiratory support rate, and mortality) of high flow nasal oxygenation versus non-invasive ventilation for patients with traumatic chest injuries.
- Conditions
- Chest Trauma
- Being tested
- high flow oxygenation
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow oxygenationProcedure or surgery
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula (HFNC) group | Active comparator | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at 60 L/min Receives: Procedure: high flow oxygenation |
| Continuous positive airway pressure (CPAP) group | Active comparator | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. Pressure will be set to 3 cm H2O for 5 minutes, then titrated according to patient comfort and tolerance, as well as clinical observation Receives: Procedure: high flow oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of intubation for mechanical ventilation
Intubation criteria included a respiratory rate of >40 breaths per minute, signs of increased breathing effort, SpO2 of <90% despite high FiO2 or acidosis with a pH of <7.35,occurrence of hemodynamic instability or deterioration of neurologic status.
Measured: 48 hours
Secondary outcomes (2)
the Comfort levels with the different modes of oxygen delivery
will be measured using a 5-point with Likert Scale (marked improvement, slight improvement, no change, slight deterioration, or marked deterioration)
Measured: 48 hours
the perceived effort of breathing with the different modes of oxygen delivery
will be measured using the modified Borg Scale (0-10)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Nov 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- 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
- Model description
- The patients will be randomly allocated into two groups; patients will receive high-flow nasal oxygenation via nasal cannula (HFNC) or continuous positive airway pressure (CPAP)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huda Fahmy Mahmoud, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huda Fahmy Mahmoud, PhD, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342103
- Sponsor's protocol ID
- 559/9/2021
- Status last verified
- Nov 2022
- First submitted
- 18 Apr 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygenation Versus Non-invasive Ventilation for Patients With Blunt Chest Trauma: A Comparative Study
- ClinicalTrials.gov ID
- NCT05342103
- Acronym / sponsor ID
- 559/9/2021
- Conditions
- Chest Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Huda Fahmy Mahmoud, PhDUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 22 Apr 2022 (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.
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity, especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized. In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay. Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing ARDS after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.
Detailed description
In the past years, High-flow nasal cannula oxygen (HFNC) has gained an important popularity among intensivest to manage patients with acute respiratory failure, filling a gap in the ventilatory support escalation between facemask oxygen and non-invasive or invasive mechanical ventilation. Interestingly, the use of HFNC was widely and rapidly adopted in ICUs.A unique feature of HFNC is its ability to comfortably deliver high flows of warmed humidified gas, 20-70 L min, with a FiO2 range of 0.21-1.0. Physiological responses to HFNC therapy include increases in airway pressure, end-expiratory lung volume (EELV), and oxygenation which are probably optimal with higher flows (60-70 L/min), while the effects on dead-space washout work of breathing, and respiratory rate may be obtained with intermediate flows (20-45 L/min).
Many studies have found that high flow nasal oxygen is much better tolerated by patients compared to non-invasive ventilation, which may improve compliance. Nevertheless, there is no clear consensus on the treatment outcomes (such as intubation rate, escalated respiratory support rate, and mortality) of high flow nasal oxygenation versus non-invasive ventilation for patients with traumatic chest injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomly allocated into two groups; patients will receive high-flow nasal oxygenation via nasal cannula (HFNC) or continuous positive airway pressure (CPAP)
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula (HFNC) group | Active comparator | Procedure: high flow oxygenationAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at 60 L/min |
| Continuous positive airway pressure (CPAP) group | Active comparator | Procedure: high flow oxygenationAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. Pressure will be set to 3 cm H2O for 5 minutes, then titrated according to patient comfort and tolerance, as well as clinical observation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Rib fractures, pulmonary contusion, and admission within 24 h of injury
- Hypoxemia (SpO2 90 % while breathing 10 l/min oxygen in the ER), or hypercapnia (PaCO2 45 mm Hg) on study entry
- respiratory rate 25/ min despite an optimized intravenous analgesia
- No indication of mechanical ventilation at the time of admission to the intensive care unit
Key exclusion criteria (6 listed)
- Patients < 18 years old
- Patient already admitted to ICU on mechanical ventilation
- requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
- facial fractures or base of skull fractures
- Who did not receive a chest computed tomography (CT) scan
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 oxygenationAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. | Procedure or surgery | Continuous positive airway pressure (CPAP) group, High flow nasal cannula (HFNC) group |
Primary outcome
the rate of intubation for mechanical ventilation
Time frame: 48 hours
Intubation criteria included a respiratory rate of >40 breaths per minute, signs of increased breathing effort, SpO2 of <90% despite high FiO2 or acidosis with a pH of <7.35,occurrence of hemodynamic instability or deterioration of neurologic status.
2 secondary outcomes
the Comfort levels with the different modes of oxygen delivery
Time frame: 48 hours
the perceived effort of breathing with the different modes of oxygen delivery
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow oxygenation in people with Chest Trauma, run by Huda Fahmy Mahmoud, PhD at 1 site in Egypt.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the rate of intubation for mechanical ventilation (time frame: 48 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 20 Jan 2023.