Clinical trial NCT05692076: Role of HVNI in Severe Chest Trauma
Official title: The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chest Trauma
Keywords: High velocity nasal insufflation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 86
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

Brief 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

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.

Eligibility criteria: 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 )

Primary outcomes:
measure: Incidence of atelectasis in chest trauma patients
timeFrame: 3 years
Secondary outcomes:
measure: respiratory complications,hospital stay and Comfort levels
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
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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.