Serial Daily Diaphragm Ultrasounds in Ventilated Patients

Muscle Atrophy or Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174029
• Other study ID #: 2013130
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: March 9, 2015
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Injury
• Muscle Atrophy or Weakness
• Muscular Atrophy
• 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.
• 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
Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Steve Reynolds	Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	US measurement of diaphragm and quadriceps thickness	Diaphragm thickness will be measured once per day and continue until extubation, liberation from mechanical ventilation, transfer to another facility, death, or study completion.	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	No
Secondary	Quadriceps muscle thickness	The thickness of the quadriceps muscle on ultrasound will be measured daily until patient exit from study	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	No
Secondary	PEEP (Postive end expiratory pressure) applied by the mechanical ventilator at the time of the ultraspound	The PEEP (as described above in the title) in cm H20 as applied by the mechanical ventilator, measured at the time of ultrasound	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	No
Secondary	re-intubated within 48 hours	Whether a patient required re-intubation within 48 hours of extubation	followed for 48 hours post extubation, or 3 month study period has ended	No
Secondary	mean daily fluid balance	Fluid balance of administer fluids minus measurable excreted fluid as recorded every 24 hours by the bedside nurse	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	No
Secondary	mean daily FiO2 (oxygen level administered)	The daily average oxygen delivered through the mechanical ventilator to the patient.	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	No
Secondary	mode of mechanical ventilation for >80% of the day	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).	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	No
Secondary	steroids given	This will include any dose of steroids administered to the patient each day during their intubation.	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	No
Secondary	vasopressors given	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.	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	No
Secondary	paralytics given	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	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	No
Secondary	30 day mortality	This is to capture all cause mortality. A patient will be considered to have survived if they are discharged from hospital.	30 days after patient is extubated, or at the end of the follow up period 1 month after the 3 month study has ended	No
Secondary	Body Mass Index (BMI)	The standard BMI will be recorded as determined by the clinical dietician.	from admission information, at the time of admission to the ICU, obtained from the patient record	No
Secondary	presence of sepsis/severe sepsis on admission	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.	from admission information, at the time of admission to the ICU, obtained from the patient record.	No
Secondary	% Caloric goals met in preceding 24 hours	A % of caloric goals delivered over the preceding 24 hours will be captured	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	No
Secondary	Initial presence of malnutrition	Presence of malnutrition as assessed by dietician on admission	Measure at the time of admission to the ICU	No
Secondary	At risk for re-feeding syndrome	Presence of risk for re-feeding syndrome as assessed by dietician on admission	Assessed on admission to the ICU	No