Chest TraumaNCT05692076
Role of HVNI in Severe Chest Trauma
A study testing High Velocity Nasal Insufflation in people with Chest Trauma, run by Assiut University.
Trial summary
to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Chest Trauma
- What is being tested?
- High Velocity Nasal Insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2023to 20 Sep 2025
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chest trauma patients with lung injury confirmed by ct imaging
- the age from 15-55 years old
- No indication of mechanical ventilation at the time of admission to the intensive care unit
Who cannot join
- • Patients < 15years old
- 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 <10
- Massive surgical emphysema
- COPD Patients ( chronic obstructive pulmonary disease )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma
to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma
Read the detailed description
- Chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia.
- The two main goals of therapy are pain management and pulmonary care and support. There is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis.
- Oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures.
High -velocity nasal insufflation (HVNI ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. Positive end-expiratory pressure can be generated, preventing alveoli collapse. The washout of carbon dioxide (CO2)and replacement with enriched O2 purportedly decreases work of breathing and increases breathing effectiveness.
- Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation .
- In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. The ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.
- Conditions
- Chest Trauma
- Being tested
- High Velocity Nasal Insufflation
- Keywords
- High velocity nasal insufflation
- 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 Velocity Nasal InsufflationDevice
High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.
| Study group | Role | What they receive |
|---|---|---|
| HVNI group | Experimental | Patients will receive high velocity nasal insufflation therapy Receives: Device: High Velocity Nasal Insufflation |
| Control group | Other | Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask Receives: Device: High Velocity Nasal Insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atelectasis in chest trauma patients
Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.
Measured: 3 years
Secondary outcomes (1)
respiratory complications,hospital stay and Comfort levels
Other respiratory complications as hypoxemia and pneumonia.
- Need for intubation and mechanical ventilation
- Length of ICU and hospital stay.
- Comfort levels with different levels of oxygen delivery measured by Likert scale.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- • we sought statistical advice regarding the sample size needed for the study sample size was calculated using G power program to detect significant difference. * To detect the incidence of atelectasis in these patients we performed a pilot study included 15 patients using simple mask as oxygen therapy, the results showed an incidence of 50% rate of atelectasis according to the inclusion and exclusion criteria * To be able to detect 30% reduction in the incidence of atelectasis we need to include 43 patients in each group * Alpha error=.05, 80 % power of the study with equal group assignment Group (A) :43 patients (control group): • Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask Group (B) 43 patients ( HVNI group): • Patient will receive HVNI therapy
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Yasser Abdelgaber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692076
- Sponsor's protocol ID
- HVNI in severe chest trauma
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karim A, Arora VK. Applications of ultrasonography in respiratory intensive care. Indian J Chest Dis Allied Sci. 2014 Jan-Mar;56(1):27-31.
PubMed 24930204Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
PubMed 11548565McGillicuddy D, Rosen P. Diagnostic dilemmas and current controversies in blunt chest trauma. Emerg Med Clin North Am. 2007 Aug;25(3):695-711, viii-ix. doi: 10.1016/j.emc.2007.06.004.
PubMed 17826213Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.
PubMed 26969671Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4.
PubMed 29558988Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PubMed 25866645Abdalla W, Elgendy M, Abdelaziz AA, Ammar MA. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study. Saudi J Anaesth. 2016 Jul-Sep;10(3):265-9. doi: 10.4103/1658-354X.174906.
PubMed 27375379Wongwaisayawan S, Suwannanon R, Sawatmongkorngul S, Kaewlai R. Emergency Thoracic US: The Essentials. Radiographics. 2016 May-Jun;36(3):640-59. doi: 10.1148/rg.2016150064. Epub 2016 Apr 1.
PubMed 27035835
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
- The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma
- ClinicalTrials.gov ID
- NCT05692076
- Acronym / sponsor ID
- HVNI in severe chest trauma
- Conditions
- Chest Trauma
- Keywords
- High velocity nasal insufflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 20 Jan 2023 (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.
to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma
Detailed description
- Chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia.
- The two main goals of therapy are pain management and pulmonary care and support. There is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis.
- Oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures.
High -velocity nasal insufflation (HVNI ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. Positive end-expiratory pressure can be generated, preventing alveoli collapse. The washout of carbon dioxide (CO2)and replacement with enriched O2 purportedly decreases work of breathing and increases breathing effectiveness.
- Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation .
- In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. The ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- • we sought statistical advice regarding the sample size needed for the study sample size was calculated using G power program to detect significant difference. * To detect the incidence of atelectasis in these patients we performed a pilot study included 15 patients using simple mask as oxygen therapy, the results showed an incidence of 50% rate of atelectasis according to the inclusion and exclusion criteria * To be able to detect 30% reduction in the incidence of atelectasis we need to include 43 patients in each group * Alpha error=.05, 80 % power of the study with equal group assignment Group (A) :43 patients (control group): • Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask Group (B) 43 patients ( HVNI group): • Patient will receive HVNI therapy
| Arm | Type | Receives |
|---|---|---|
| HVNI group | Experimental | Device: High Velocity Nasal InsufflationPatients will receive high velocity nasal insufflation therapy |
| Control group | Other | Device: High Velocity Nasal InsufflationPatient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Chest trauma patients with lung injury confirmed by ct imaging
Key exclusion criteria (7 listed)
- • Patients < 15years old
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 Velocity Nasal InsufflationHigh-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. | Device | Control group, HVNI group |
Primary outcome
Incidence of atelectasis in chest trauma patients
Time frame: 3 years
Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.
1 secondary outcome
respiratory complications,hospital stay and Comfort levels
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 24930204Karim A, Arora VK. Applications of ultrasonography in respiratory intensive care. Indian J Chest Dis Allied Sci. 2014 Jan-Mar;56(1):27-31.
- Background: PubMed 11548565Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
- Background: PubMed 17826213McGillicuddy D, Rosen P. Diagnostic dilemmas and current controversies in blunt chest trauma. Emerg Med Clin North Am. 2007 Aug;25(3):695-711, viii-ix. doi: 10.1016/j.emc.2007.06.004.
- Background: PubMed 26969671Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11.
- Background: PubMed 29558988Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4.
- Background: PubMed 25866645Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
- Background: PubMed 27375379Abdalla W, Elgendy M, Abdelaziz AA, Ammar MA. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study. Saudi J Anaesth. 2016 Jul-Sep;10(3):265-9. doi: 10.4103/1658-354X.174906.
- Background: PubMed 27035835Wongwaisayawan S, Suwannanon R, Sawatmongkorngul S, Kaewlai R. Emergency Thoracic US: The Essentials. Radiographics. 2016 May-Jun;36(3):640-59. doi: 10.1148/rg.2016150064. Epub 2016 Apr 1.
- Related InfoLink provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Nasal Insufflation in people with Chest Trauma, run by Assiut University.
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 3 inclusion and 7 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 20 Jan 2023. 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. 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?
Contact Mohamed Yasser, Bachelor's (01066249910, my3939899@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atelectasis in chest trauma patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692076, which also lists 8 linked publications.
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.