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Clinical Trials/NCT02174029
NCT02174029
Completed
Not Applicable

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

Steve Reynolds1 site in 1 country61 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Muscle Atrophy or Weakness
Sponsor
Steve Reynolds
Enrollment
61
Locations
1
Primary Endpoint
US measurement of diaphragm and quadriceps thickness
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
September 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Steve Reynolds
Responsible Party
Sponsor Investigator
Principal Investigator

Steve Reynolds

Head and Research Director, Department of Critical Care, Royal Columbian Hospital

Fraser Health

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

Outcomes

Primary Outcomes

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

  • Quadriceps muscle thickness(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)
  • re-intubated within 48 hours(followed for 48 hours post extubation, or 3 month study period has ended)
  • mean daily FiO2 (oxygen level administered)(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)
  • mean daily fluid balance(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)
  • presence of sepsis/severe sepsis on admission(from admission information, at the time of admission to the ICU, obtained from the patient record.)
  • Initial presence of malnutrition(Measure at the time of admission to the ICU)
  • paralytics given(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)
  • Body Mass Index (BMI)(from admission information, at the time of admission to the ICU, obtained from the patient record)
  • At risk for re-feeding syndrome(Assessed on admission to the ICU)
  • PEEP (Postive end expiratory pressure) applied by the mechanical ventilator at the time of the ultraspound(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)
  • 30 day mortality(30 days after patient is extubated, or at the end of the follow up period 1 month after the 3 month study has ended)
  • mode of mechanical ventilation for >80% of the day(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)
  • steroids given(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)
  • vasopressors given(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)
  • % Caloric goals met in preceding 24 hours(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)

Study Sites (1)

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