Mechanical Ventilation in Multiple Fracture Ribs

Study Overview
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Brief Summary
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Chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. Severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. Mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis

Detailed Description
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To compare between Biphasic Intermittent Positive Airway Pressure (BIPAP) ventilation and Airway Pressure Release Ventilation (APRV) mode in patients with multiple fracture ribs as regard: Resting Energy Expenditure Oxygenation Stability of Physiological Status as cardiovascular activity cardiac output arterial blood gas measurement including [ blood PH, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit] lung and chest compliance Length of intensive care unit stay. The ICU mortality rate. The development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.

Official Title
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Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)
* Device: Airway Pressure Release Ventilation (APRV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Isolated chest trauma patient with Multiple fracture ribs patients [ >3 ribs] who will be admitted to the surgical ICU for ventilatory support and will be expected to continue for 2 days or longer Exclusion Criteria: Age < 18 years old. Pregnant patient. Patient who will require fraction of inspired oxygen more than 0.6. Air leak from the chest tube. Patient with body temperature > 39 Celsius. Acute hepatitis or severe liver disease (Child-Pugh class C). Left ventricular ejection fraction less than 30%. Heart rate less than 50 beats/min. Second or third-degree heart block. Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors. Patients with known endocrine dysfunction. Patient with hypothermia Patient on Positive end expiratory pressure more than 14 cmH2o

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Biphasic Intermittent Positive Airway Pressure (BIPAP) group: Following endotracheal intubation BIPAP mode will be started with: Inspiratory positive airway pressure [IPAP] at 20 cmH2O Expiratory positive airway pressure [EPAP] at 5 cmH2O PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP] Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed | Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)<br>* Following endotracheal intubation BIPAP mode will be started with: Inspiratory positive airway pressure [IPAP] at 20 cmH2O Expiratory positive airway pressure [EPAP] at 5 cmH2O PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP] Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed<br>|
| Active Comparator: Group 2<br>Airway Pressure Release Ventilation (APRV) group: high airway pressure (Phigh) will be set at 20 cmH2O low airway pressure ( Plow) will be set at 5 cmH2O the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min T high at 4.5-6 seconds T low at 0.5 to 0.8 second | Device: Airway Pressure Release Ventilation (APRV)<br>* high airway pressure (Phigh) will be set at 20 cmH2O low airway pressure ( Plow) will be set at 5 cmH2O the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min T high at 4.5-6 seconds T low at 0.5 to 0.8 second<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | The total duration of ventilatory support in both groups from randomization to successful weaning (hours) | within one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Energy Expenditure | Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860] | within the first 48 hours | 
| Physiological dead space | Physiological dead space will be measured in the two groups after 30 minutes by Volumetric capnography which is included in the metabolic module on General Electric ventilator | within the first 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resting Energy Expenditure, Multiple Fracture Ribs, Ventilation