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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05692076
Other study ID # HVNI in severe chest trauma
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 20, 2023
Est. completion date September 20, 2025

Study information

Verified date January 2023
Source Assiut University
Contact Mohamed Yasser, Bachelor's
Phone 01066249910
Email my3939899@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 86
Est. completion date September 20, 2025
Est. primary completion date March 20, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - • 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 )

Study Design


Related Conditions & MeSH terms


Intervention

Device:
High Velocity Nasal Insufflation
High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

Abdalla 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. — View Citation

Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9. — View Citation

Helviz 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. — View Citation

Karim A, Arora VK. Applications of ultrasonography in respiratory intensive care. Indian J Chest Dis Allied Sci. 2014 Jan-Mar;56(1):27-31. — View Citation

McGillicuddy 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. — View Citation

Nishimura 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. — View Citation

Papazian 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. — View Citation

Wongwaisayawan 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of atelectasis in chest trauma patients Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score. 3 years
Secondary 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.
3 years
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