Mechanical Ventilation in Multiple Fracture Ribs

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03314701

Collaborator

(none)

Enrollment

Location

Arms

13.2

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation	Device: Biphasic Intermittent Positive Airway Pressure (BIPAP) Device: Airway Pressure Release Ventilation (APRV)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 25, 2017

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Duration of mechanical ventilation [within one month]
The total duration of ventilatory support in both groups from randomization to successful weaning (hours)

Secondary Outcome Measures

Resting Energy Expenditure [within the first 48 hours]
Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]
Physiological dead space [within the first 48 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sayed Kaoud Abd-Elshafy, Associate Professor of Anesthesiology and Critical Care, Assiut University

ClinicalTrials.gov Identifier:

NCT03314701

Other Study ID Numbers:

IRB0000879659

First Posted:

Oct 19, 2017

Last Update Posted:

Jul 9, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sayed Kaoud Abd-Elshafy, Associate Professor of Anesthesiology and Critical Care, Assiut University

Resting Energy Expenditure

Multiple Fracture Ribs

Ventilation

Additional relevant MeSH terms:

Rib Fractures

Fractures, Multiple

Study Results

No Results Posted as of Jul 9, 2018