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Status unknownNCT03314701Updated Jul 9, 2018

Mechanical Ventilation in Multiple Fracture Ribs

An interventional study of Biphasic Intermittent Positive Airway Pressure (BIPAP) and Airway Pressure Release Ventilation (APRV) in Mechanical Ventilation, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-09.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Mechanical Ventilation

Keywords

  • Resting Energy Expenditure
  • Multiple Fracture Ribs
  • Ventilation
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • DeviceBiphasic 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

  • DeviceAirway 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

05

What researchers measure

Primary outcomes

  1. Duration of mechanical ventilation

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

    Time frame: within one month

Secondary outcomes

  1. Resting Energy Expenditure

    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

  2. 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

    Time frame: within the first 48 hours

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03314701
Lead sponsor
Assiut University
Responsible party
Sayed Kaoud Abd-Elshafy (Associate Professor of Anesthesiology and Critical Care, Assiut University) — Principal investigator
First posted
Oct 19, 2017
Start date
Oct 25, 2017
Primary completion
Oct 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jul 9, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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