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Completed

NCT Number: NCT02174029

Serial Daily Diaphragm Ultrasounds in Ventilated Patients

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.

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Key information

Conditions

Muscle Atrophy or Weakness Asthenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Ventilator-Associated Lung Injury

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilation- mandatory

Procedure

Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.

Ventilation- voluntary mode only

Procedure

Patient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode

Voluntary with preceding mandatory

Procedure

Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Steve Reynolds

Other

Collaborators

  • Fraser Health

Registry information

Official study title

Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU Patients

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2014
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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