Mechanical Ventilation in Multiple Fracture Ribs

Not Applicable

• Conditions: Mechanical Ventilation
• Interventions: Device: Airway Pressure Release Ventilation (APRV); Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)

• Registration Number: NCT03314701
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-10-18
• Study First Posted: 2017-10-19
• Study Start: 2017-10-25
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Airway Pressure Release Ventilation (APRV)	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
Group 1	Biphasic Intermittent Positive Airway Pressure (BIPAP)	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

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	within one month	The total duration of ventilatory support in both groups from randomization to successful weaning (hours)

Secondary Outcome Measures

Name	Time	Method
Physiological dead space	within the first 48 hours	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
Resting Energy Expenditure	within the first 48 hours	Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator \[CARESCAPE R860\]

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt