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Mechanical Ventilation in Multiple Fracture Ribs

A

Assiut University

Status

Unknown

Conditions

Mechanical Ventilation

Treatments

Device: Airway Pressure Release Ventilation (APRV)
Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT03314701
IRB0000879659

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Group 1
Active Comparator group
Description:
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
Treatment:
Device: Biphasic Intermittent Positive Airway Pressure (BIPAP)
Group 2
Active Comparator group
Description:
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
Treatment:
Device: Airway Pressure Release Ventilation (APRV)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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