Muscle Atrophy or WeaknessNCT02174029
Serial Daily Diaphragm Ultrasounds in Ventilated Patients
An observational study of Muscle Atrophy or Weakness and Ventilator-associated Lung Injury, run by Steve Reynolds at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Muscle Atrophy or Weakness, Ventilator-associated Lung Injury
- What is being tested?
- Ventilation- mandatory, Ventilation- voluntary mode only and Voluntary with preceding mandatory
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated critical ill patients
Who may be able to join
- All patients age ≥19 years in the ICU on ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
About this study
Official title: Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU 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.
Read more
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.
Read the 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.
- Being tested
- Ventilation- mandatory, Ventilation- voluntary mode only, Voluntary with preceding mandatory
- Keywords
- Atrophy, Ventilator, Induced, Diaphragm, Dysfunction
- Medical subject headings
- Muscular Atrophy, Asthenia, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation- mandatoryProcedure or surgery
Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.
Ventilation- voluntary mode onlyProcedure or surgery
Patient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode
Voluntary with preceding mandatoryProcedure or surgery
Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation- mandatory mode only | those patient ventilator days during which they had only received a mandatory mode of ventilation Receives: 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. Receives: 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. Receives: Procedure: Voluntary with preceding mandatory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (15)
Quadriceps muscle thickness
The thickness of the quadriceps muscle on ultrasound will be measured daily until patient exit from study
Measured: 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
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
Measured: 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
Whether a patient required re-intubation within 48 hours of extubation
Measured: followed for 48 hours post extubation, or 3 month study period has ended
mean daily fluid balance
Fluid balance of administer fluids minus measurable excreted fluid as recorded every 24 hours by the bedside nurse
Measured: 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 FiO2 (oxygen level administered)
The daily average oxygen delivered through the mechanical ventilator to the patient.
Measured: 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 >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).
Measured: 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
This will include any dose of steroids administered to the patient each day during their intubation.
Measured: 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
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.
Measured: 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
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
Measured: 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
30 day mortality
This is to capture all cause mortality. A patient will be considered to have survived if they are discharged from hospital.
Measured: 30 days after patient is extubated, or at the end of the follow up period 1 month after the 3 month study has ended
Body Mass Index (BMI)
The standard BMI will be recorded as determined by the clinical dietician.
Measured: from admission information, at the time of admission to the ICU, obtained from the patient record
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.
Measured: from admission information, at the time of admission to the ICU, obtained from the patient record.
% Caloric goals met in preceding 24 hours
A % of caloric goals delivered over the preceding 24 hours will be captured
Measured: 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
Initial presence of malnutrition
Presence of malnutrition as assessed by dietician on admission
Measured: Measure at the time of admission to the ICU
At risk for re-feeding syndrome
Presence of risk for re-feeding syndrome as assessed by dietician on admission
Measured: Assessed on admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Atrophy or WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steve Reynolds
- Sponsor type
- University, hospital or other
- Collaborators
- Fraser Health
- Responsible party
- Sponsor-investigator, Steve Reynolds, Fraser Health
- Investigators
- Steven Reynolds, MD, Principal investigator, Royal Columbian Hospital, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174029
- Sponsor's protocol ID
- 2013130
- Status last verified
- Mar 2015
- First submitted
- 27 May 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Ultrasonographic Evaluation Of Diaphragm Thickness During Mechanical Ventilation In ICU Patients
- ClinicalTrials.gov ID
- NCT02174029
- Acronym / sponsor ID
- 2013130
- Keywords
- Atrophy, Ventilator, Induced, Diaphragm, Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Steve ReynoldsUniversity, hospital or other
- Collaborators
- Fraser Health
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ventilation- mandatory mode only | – | Procedure: Ventilation- mandatorythose patient ventilator days during which they had only received a mandatory mode of ventilation |
| Ventilation- voluntary mode only | – | Procedure: Ventilation- voluntary mode onlyThose patient days on a mechanical ventilator who have not received prior mandatory ventilation during this episode of mechanical ventilation. |
| voluntary with preceding mandatory | – | Procedure: Voluntary with preceding mandatoryThose patient ventilator days where the patient had at least one prior day of mandatory mechanical ventilation during this episode of respiratory support. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated critical ill patients
Key inclusion criteria (1 listed)
- All patients age ≥19 years in the ICU on ventilation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation- mandatoryPatient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used. | Procedure or surgery | Ventilation- mandatory mode only |
| Ventilation- voluntary mode onlyPatient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode | Procedure or surgery | Ventilation- voluntary mode only |
| Voluntary with preceding mandatoryPatient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory. | Procedure or surgery | voluntary with preceding mandatory |
Primary outcome
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.
15 secondary outcomes
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
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
re-intubated within 48 hours
Time frame: followed for 48 hours post extubation, or 3 month study period has ended
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
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
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
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
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
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
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
Body Mass Index (BMI)
Time frame: from admission information, at the time of admission to the ICU, obtained from the patient record
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.
% 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
Initial presence of malnutrition
Time frame: Measure at the time of admission to the ICU
At risk for re-feeding syndrome
Time frame: Assessed on admission to the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Reynolds, MD principal investigator
Royal Columbian Hospital, Fraser Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Atrophy or Weakness and Ventilator-associated Lung Injury, run by Steve Reynolds at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.