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Trial record 35 of 74 for:    Recruiting, Not yet recruiting, Available Studies | "Thoracic Injuries"

Mechanical Ventilation in Multiple Fracture Ribs

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ClinicalTrials.gov Identifier: NCT03314701
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sayed Kaoud Abd-Elshafy, Assiut University

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) Not Applicable

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  (Clinical Trial)
Estimated 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 : October 25, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: within one month ]
    The total duration of ventilatory support in both groups from randomization to successful weaning (hours)


Secondary Outcome Measures :
  1. Resting Energy Expenditure [ Time Frame: within the first 48 hours ]
    Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]

  2. Physiological dead space [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314701


Locations
Egypt
Faculty of Medicine Recruiting
Assiut, Egypt
Contact: mohamed abdelatef, MD    0020882413201    latif_mohamed@hotmail.com   
Sponsors and Collaborators
Assiut University

Responsible Party: Sayed Kaoud Abd-Elshafy, Associate Professor of Anesthesiology and Critical Care, Assiut University
ClinicalTrials.gov Identifier: NCT03314701     History of Changes
Other Study ID Numbers: IRB0000879659
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sayed Kaoud Abd-Elshafy, Assiut University:
Resting Energy Expenditure
Multiple Fracture Ribs
Ventilation

Additional relevant MeSH terms:
Rib Fractures
Fractures, Multiple
Fractures, Bone
Wounds and Injuries
Thoracic Injuries
Multiple Trauma