Role of HVNI in Severe Chest Trauma

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma

Conditions
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Chest Trauma

Intervention / Treatment
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* Device: High Velocity Nasal Insufflation


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVNI group<br>Patients will receive high velocity nasal insufflation therapy | Device: High Velocity Nasal Insufflation<br>* High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.<br>|
| Other: Control group<br>Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask | Device: High Velocity Nasal Insufflation<br>* High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High velocity nasal insufflation