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Mechanical Ventilation in Multiple Fracture Ribs

Primary Purpose

Mechanical Ventilation

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biphasic Intermittent Positive Airway Pressure (BIPAP)
Airway Pressure Release Ventilation (APRV)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Ventilation focused on measuring Resting Energy Expenditure, Multiple Fracture Ribs, Ventilation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resting Energy Expenditure
Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]
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

Full Information

First Posted
October 14, 2017
Last Updated
July 6, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03314701
Brief Title
Mechanical Ventilation in Multiple Fracture Ribs
Official Title
Biphasic Intermittent Positive Airway Pressure (BIPAP) Versus Airway Pressure Release Ventilation (APRV) in Patients With Multiple Fracture Ribs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation
Keywords
Resting Energy Expenditure, Multiple Fracture Ribs, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Biphasic Intermittent Positive Airway Pressure (BIPAP)
Intervention Description
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
Intervention Name(s)
Airway Pressure Release Ventilation (APRV)
Intervention Description
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 Measure Information:
Title
Duration of mechanical ventilation
Description
The total duration of ventilatory support in both groups from randomization to successful weaning (hours)
Time Frame
within one month
Secondary Outcome Measure Information:
Title
Resting Energy Expenditure
Description
Energy expenditure will be measured using indirect calorimetry via a metabolic module on General Electric ventilator [CARESCAPE R860]
Time Frame
within the first 48 hours
Title
Physiological dead space
Description
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
Time Frame
within the first 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed abdelatef, MD
Phone
0020882413201
Email
latif_mohamed@hotmail.com

12. IPD Sharing Statement

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Mechanical Ventilation in Multiple Fracture Ribs

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