Clinical trial NCT02174029: Serial Daily Diaphragm Ultrasounds in Ventilated Patients
Official title: Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Atrophy or Weakness
Ventilator-associated Lung Injury
Keywords: Atrophy
Ventilator
Induced
Diaphragm
Dysfunction
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Fraser Health
First posted: 2014-06-25
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated critical ill 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.

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

Primary outcomes:
measure: US measurement of diaphragm and quadriceps thickness
timeFrame: 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
Secondary outcomes:
measure: Quadriceps muscle thickness
timeFrame: 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
measure: PEEP (Postive end expiratory pressure) applied by the mechanical ventilator at the time of the ultraspound
timeFrame: 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
measure: re-intubated within 48 hours
timeFrame: followed for 48 hours post extubation, or 3 month study period has ended
measure: mean daily fluid balance
timeFrame: 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
measure: mean daily FiO2 (oxygen level administered)
timeFrame: 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
measure: mode of mechanical ventilation for >80% of the day
timeFrame: 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
measure: steroids given
timeFrame: 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
measure: vasopressors given
timeFrame: 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
measure: paralytics given
timeFrame: 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
measure: 30 day mortality
timeFrame: 30 days after patient is extubated, or at the end of the follow up period 1 month after the 3 month study has ended
measure: Body Mass Index (BMI)
timeFrame: from admission information, at the time of admission to the ICU, obtained from the patient record
measure: presence of sepsis/severe sepsis on admission
timeFrame: from admission information, at the time of admission to the ICU, obtained from the patient record.
measure: % Caloric goals met in preceding 24 hours
timeFrame: 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
measure: Initial presence of malnutrition
timeFrame: Measure at the time of admission to the ICU
measure: At risk for re-feeding syndrome
timeFrame: Assessed on admission to the ICU
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Royal Columbian Hospital, Fraser Health
name: Steven Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: