Mechanical Ventilation in Multiple Fracture Ribs

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

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

Study Overview

• Status: Unknown
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Device: Biphasic Intermittent Positive Airway Pressure (BIPAP); Device: Airway Pressure Release Ventilation (APRV)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 14, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ventilation; Resting Energy Expenditure; Multiple Fracture Ribs
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: IRB0000879659

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No