Mechanical Ventilation in Multiple Fracture Ribs

NCT ID: NCT03314701

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-25
• Study Completion Date: 2018-12-31

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.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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

Group Type: ACTIVE_COMPARATOR

Biphasic Intermittent Positive Airway Pressure (BIPAP)

Intervention Type: DEVICE

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

Group 2

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 Type: ACTIVE_COMPARATOR

Airway Pressure Release Ventilation (APRV)

Intervention Type: DEVICE

• 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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Kaoud Abd-Elshafy

Associate Professor of Anesthesiology and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

mohamed abdelatef, MD

Role: primary

latif_mohamed@hotmail.com

0020882413201

Other Identifiers

IRB0000879659

Identifier Type: -

Identifier Source: org_study_id