Mechanical Ventilation in Multiple Fracture Ribs

NCT03314701 | Unknown DMC

• 1 other identifier: IRB0000879659
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Mechanical Ventilation

Keywords

Resting Energy Expenditure; Multiple Fracture Ribs; Ventilation

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  The total duration of ventilatory support in both groups from randomization to successful weaning (hours)

  within one month

Secondary Outcomes (2)

• Resting Energy Expenditure

  within the first 48 hours

• Physiological dead space

  within the first 48 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

ACTIVE COMPARATOR

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)

Interventions

Biphasic Intermittent Positive Airway Pressure (BIPAP) 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 1

Airway Pressure Release Ventilation (APRV) 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

Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Intermittent Positive-Pressure Ventilation; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Critical Care

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: October 19, 2017
• Study Start: October 25, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

EG (1)