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Serial Daily Diaphragm Ultrasounds in Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 27, 2014
First Posted Date June 25, 2014
Last Update Posted Date March 11, 2015
Study Start Date June 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2014)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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).
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • % 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
  • Initial presence of malnutrition [ Time Frame: Measure at the time of admission to the ICU ]
    Presence of malnutrition as assessed by dietician on admission
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Serial Daily Diaphragm Ultrasounds in Ventilated Patients
Official Title Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU Patients
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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Mechanically ventilated critical ill patients
Condition
  • Muscle Atrophy or Weakness
  • Ventilator-associated Lung Injury
Intervention
  • Procedure: Ventilation- mandatory
    Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.
  • 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
  • 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.
Study Groups/Cohorts
  • Ventilation- mandatory mode only
    those patient ventilator days during which they had only received a mandatory mode of ventilation
    Intervention: Procedure: Ventilation- mandatory
  • Ventilation- voluntary mode only
    Those patient days on a mechanical ventilator who have not received prior mandatory ventilation during this episode of mechanical ventilation.
    Intervention: Procedure: Ventilation- voluntary mode only
  • 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.
    Intervention: Procedure: Voluntary with preceding mandatory
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 9, 2015)
61
Original Estimated Enrollment
 (submitted: June 24, 2014)
200
Actual Study Completion Date September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02174029
Other Study ID Numbers 2013130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Steve Reynolds, Fraser Health
Study Sponsor Steve Reynolds
Collaborators Fraser Health
Investigators
Principal Investigator: Steven Reynolds, MD Royal Columbian Hospital, Fraser Health
PRS Account Fraser Health
Verification Date March 2015