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Serial Daily Diaphragm Ultrasounds in Ventilated Patients

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ClinicalTrials.gov Identifier: NCT02174029
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Fraser Health
Information provided by (Responsible Party):
Steve Reynolds, Fraser Health

Brief Summary:

When a person is put on a breathing machine the investigators think that the breathing muscles can get weaker. The investigators are not sure how quickly this happens but in some people this leads to problems when they try to breathe on their own without the breathing machine. The diaphragm is at the bottom of a person's chest separating their lungs from what is in their belly and it is a very strong muscle. In fact, it is main muscle that one uses for breathing.

An ultrasound machine is a painless way to see what is happening beneath the skin. It is safe and easy to do. Using an ultrasound the investigators are planning to measure how thick the diaphragm is and how much it changes while a person is on a breathing machine in the ICU.

Getting a better understanding of this condition could lead to improved treatments that might help support patients who require a ventilator for breathing.

The investigators hypothesis is that patients for whom the breathing machine is doing all of the work of breathing, will have their diaphragm thickness gradually decrease and changing to a breathing modem mode where they have to put in more effort the diaphragm thickness will start increasing again.


Condition or disease Intervention/treatment
Muscle Atrophy or Weakness Ventilator-associated Lung Injury Procedure: Ventilation- mandatory Procedure: Ventilation- voluntary mode only Procedure: Voluntary with preceding mandatory

Detailed Description:

The investigators propose to expand the investigators single-centre longitudinal pilot study into a complete study in which the investigators will use B-mode ultrasonography to evaluate daily changes in diaphragm thickness in all critically ill patients on mechanical ventilation (MV) until successful weaned from MV. The impact of patient age, co-morbidities, and the use of various modes of ventilation on diaphragm thickness will be assessed. Diaphragmatic thickness and its change from baseline will be evaluated as predictors of the need for a prolonged wean (>7days).

The investigators hypothesize that in patients on mandatory mode ventilation, diaphragmatic thickness will progressively decrease. Switching from mandatory to assisted breathing modes will correlate with increases in diaphragmatic thickness.

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU Patients
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Group/Cohort Intervention/treatment
Ventilation- mandatory mode only
those patient ventilator days during which they had only received a mandatory mode of ventilation
Procedure: Ventilation- mandatory
Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.

Ventilation- voluntary mode only
Those patient days on a mechanical ventilator who have not received prior mandatory ventilation during this episode of mechanical ventilation.
Procedure: Ventilation- voluntary mode only
Patient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode

voluntary with preceding mandatory
Those patient ventilator days where the patient had at least one prior day of mandatory mechanical ventilation during this episode of respiratory support.
Procedure: Voluntary with preceding mandatory
Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.




Primary Outcome Measures :
  1. US measurement of diaphragm and quadriceps thickness [ Time Frame: Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    Diaphragm thickness will be measured once per day and continue until extubation, liberation from mechanical ventilation, transfer to another facility, death, or study completion.


Secondary Outcome Measures :
  1. Quadriceps muscle thickness [ Time Frame: Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    The thickness of the quadriceps muscle on ultrasound will be measured daily until patient exit from study

  2. PEEP (Postive end expiratory pressure) applied by the mechanical ventilator at the time of the ultraspound [ Time Frame: Participants will be ultrasounded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    The PEEP (as described above in the title) in cm H20 as applied by the mechanical ventilator, measured at the time of ultrasound

  3. re-intubated within 48 hours [ Time Frame: followed for 48 hours post extubation, or 3 month study period has ended ]
    Whether a patient required re-intubation within 48 hours of extubation

  4. mean daily fluid balance [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    Fluid balance of administer fluids minus measurable excreted fluid as recorded every 24 hours by the bedside nurse

  5. mean daily FiO2 (oxygen level administered) [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    The daily average oxygen delivered through the mechanical ventilator to the patient.

  6. mode of mechanical ventilation for >80% of the day [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    Mode of mechanical ventilation for the >80% of the day will be recorded here. This will be split into a mandatory mode (where the machine supplies a breath) or a voluntary mode (where the patient triggers the breath and the machine supports it).

  7. steroids given [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    This will include any dose of steroids administered to the patient each day during their intubation.

  8. vasopressors given [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    This will include any dose of medications to support the blood pressure (norepinephrine, epinephrine, dopamine, dobutamine, amrinone) administered to the patient each day during their intubation.

  9. paralytics given [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    This will include any dose of paralytic medication administered to the patient each day during their intubation, except given as part of their initial intubation

  10. 30 day mortality [ Time Frame: 30 days after patient is extubated, or at the end of the follow up period 1 month after the 3 month study has ended ]
    This is to capture all cause mortality. A patient will be considered to have survived if they are discharged from hospital.

  11. Body Mass Index (BMI) [ Time Frame: from admission information, at the time of admission to the ICU, obtained from the patient record ]
    The standard BMI will be recorded as determined by the clinical dietician.

  12. presence of sepsis/severe sepsis on admission [ Time Frame: from admission information, at the time of admission to the ICU, obtained from the patient record. ]
    This will be determined as positive if there is any reference to infection in the patients admitting paperwork in conjunction with the classic SIRS (systemic inflammatory response syndrome) criteria.

  13. % Caloric goals met in preceding 24 hours [ Time Frame: Will be recorded daily until they are extubated or the 3 month study period has ended, the expected average duration of mechanical ventilation is 4.4 days at our institution ]
    A % of caloric goals delivered over the preceding 24 hours will be captured

  14. Initial presence of malnutrition [ Time Frame: Measure at the time of admission to the ICU ]
    Presence of malnutrition as assessed by dietician on admission

  15. At risk for re-feeding syndrome [ Time Frame: Assessed on admission to the ICU ]
    Presence of risk for re-feeding syndrome as assessed by dietician on admission



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Mechanically ventilated critical ill patients
Criteria

Inclusion Criteria:

  • All patients age ≥19 years in the ICU on ventilation

Exclusion Criteria:

  • History of diaphragmatic or neuromuscular disease
  • On a home ventilator
  • History of diaphragm surgery
  • Absence of adequate initial US images (3 consecutive days with at least 2 operators)
  • BMI greater than 40

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): NCT02174029


Locations
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Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Steve Reynolds
Fraser Health
Investigators
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Principal Investigator: Steven Reynolds, MD Royal Columbian Hospital, Fraser Health
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Responsible Party: Steve Reynolds, Head and Research Director, Department of Critical Care, Royal Columbian Hospital, Fraser Health
ClinicalTrials.gov Identifier: NCT02174029    
Other Study ID Numbers: 2013130
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Steve Reynolds, Fraser Health:
Atrophy
Ventilator
Induced
Diaphragm
Dysfunction
Additional relevant MeSH terms:
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Lung Injury
Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms