Mechanical VentilationEMFICNCT04333186
Expiratory Muscle Function in Critically Ill Ventilated Patients
An observational study of Mechanical Ventilation and Expiratory Muscle, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Expiratory Muscle, Critical Illness
- What is being tested?
- Data from ultrasound measurements
- How many people
- 113 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2017to 16 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient on mechanical ventilation in the intensive care
Who may be able to join
- Age > 18 years
- Invasive mechanical ventilation < 48 hours
- Expected duration of mechanical ventilation > 72 hours
Who cannot join
- Past medical history of neuromuscular disorders
- Mechanical ventilation > 48 hours within the current hospital admission
- Pregnant women
- Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081HV
About this study
Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.
The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.
Read more
Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.
Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.
- Conditions
- Mechanical Ventilation, Expiratory Muscle, Critical Illness, Muscle Atrophy or Weakness, Diaphragm
- Being tested
- Data from ultrasound measurements
- Medical subject headings
- Critical Illness, Muscular Atrophy, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data from ultrasound measurementsOther
Data from ultrasound measurements and from the electronic patient record will be obtained / analyzed. One additional blood sample will be obtained within 24 hours after inclusion, during planned blood collection (from arterial line or venous puncture).
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal expiratory muscle thickness
Thickness of the abdominal expiratory muscles measured in millimeters
Measured: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Secondary outcomes (7)
Diaphragm muscle thickness
Thickness of the diaphragm muscle measured in millimeters
Measured: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Inflammatory markers
Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
Measured: Within 24 hours after inclusion
Applied driving pressure
Appplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured in centimetre of water
Measured: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Tidal volume
Tidal volume measured in liters
Measured: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Positive end expiratory pressure
Postive end expiratory pressure measure in centimetre of water
Measured: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Extubation failure
Reintubated after extubation
Measured: From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
Readmission to ICU
Readmitted to ICU after the ICU discharge
Measured: From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start15 Feb 2017
- Primary completion28 Nov 2019
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.dr. L.M.A. Heunks, Amsterdam UMC, location VUmc
- Investigators
- Leo M Heunks, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333186
- Sponsor's protocol ID
- EMFIC
- Acronym
- EMFIC
- Status last verified
- Nov 2020
- First submitted
- 29 Mar 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Muscle Function in Critically Ill Ventilated Patients
- ClinicalTrials.gov ID
- NCT04333186
- Acronym / sponsor ID
- EMFIC / EMFIC
- Conditions
- Mechanical Ventilation, Expiratory Muscle, Critical Illness, Muscle Atrophy or Weakness, Diaphragm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 3 Apr 2020 (actual)
- 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.
Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.
The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.
Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.
Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient on mechanical ventilation in the intensive care
Key inclusion criteria (3 listed)
- Age > 18 years
- Invasive mechanical ventilation < 48 hours
- Expected duration of mechanical ventilation > 72 hours
Key exclusion criteria (4 listed)
- Past medical history of neuromuscular disorders
- Mechanical ventilation > 48 hours within the current hospital admission
- Pregnant women
- Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery
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 |
|---|---|---|
| Data from ultrasound measurementsData from ultrasound measurements and from the electronic patient record will be obtained / analyzed. One additional blood sample will be obtained within 24 hours after inclusion, during planned blood collection (from arterial line or venous puncture). | Other | – |
Primary outcome
Abdominal expiratory muscle thickness
Time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Thickness of the abdominal expiratory muscles measured in millimeters
7 secondary outcomes
Diaphragm muscle thickness
Time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Inflammatory markers
Time frame: Within 24 hours after inclusion
Applied driving pressure
Time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Tidal volume
Time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Positive end expiratory pressure
Time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
Extubation failure
Time frame: From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
Readmission to ICU
Time frame: From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks
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 10 Nov 2020.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Mechanical Ventilation
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
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.
Leo M Heunks principal investigator
Amsterdam UMC, location VUmc
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 Mechanical Ventilation and Expiratory Muscle, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 4 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 10 Nov 2020. 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 Netherlands. 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?
Abdominal expiratory muscle thickness (time frame: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks). 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 10 Nov 2020.