Mechanical Ventilation in Multiple Fracture Ribs

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03314701
• Other study ID #: IRB0000879659
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Rib Fractures

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	The total duration of ventilatory support in both groups from randomization to successful weaning (hours)	within one month
Secondary	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
Secondary	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