Critical IllnessNMCiCIPNCT04541602
Detection of Neuromuscular Complications in Critically Ill Patients
An observational study of Critical Illness and Dysphagia, run by University of Rostock at 1 site in Germany.
Trial summary
Dysphagia and the intensive care unit-acquired weakness (ICU-AW) are common and outcome-relevant neuromuscular complications in critically ill patients, especially after prolonged mechanical ventilation, sepsis and multi-organ failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Dysphagia, Intensive Care Unit Acquired Weakness
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2020to 8 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted to the intensive care units of the study center will be screened for study eligibility according to the inclusion and exclusion criteria. Additionally, healthy volunteers will be recruited to participate as controls.
Who may be able to join
- adult patients above 17 years of age
- Sequential organ failure assessment (SOFA) score ≥8 within the first two days after ICU admission
- invasive mechanical ventilation ≥48 hours
Who cannot join
- no written informed consent from patient or legal representative
- participation in another interventional study
- patient transfer from another hospital (>1 day hospital stay)
- preexisting swallowing disorder or disease of the larynx, pharynx or esophagus
- previous surgery of the larynx, pharynx, esophagus or maxillofacial surgery
- preexisting neuromuscular diseases
- preexisting central nervous system diseases (stroke, hemorrhage, tumor, traumatic brain injury, brain surgery, epilepsy, hydrocephalus)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, University Medical Center Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Official title: Value of Neuromuscular Ultrasound and Blood Biomarkers for the Detection, Monitoring and Prognostication of Neuromuscular Complications in Critically Ill Patients: a Prospective Single-center Observational Study
Dysphagia and the intensive care unit-acquired weakness (ICU-AW) are common and outcome-relevant neuromuscular complications in critically ill patients, especially after prolonged mechanical ventilation, sepsis and multi-organ failure. However, the impact of these two complications on the clinical course of critically ill patients needs further investigation.
Furthermore, the standard diagnostic procedure to detect and grade the acquired dysphagia using the fiberoptic endoscopic evaluation of swallowing (FEES) and the Medical Research Council sum score (MRC-ss) to detect ICU-AW are time-consuming and strongly dependent on patient compliance. An early and easy-to-use detection of these neuromuscular complications is currently difficult to be achieved in this patient population.
Neuromuscular ultrasound (NMUS) and the measurement of neuromuscular damage blood biomarkers became increasingly interesting for clinical researchers in the recent years due to their broad availability and their simple and non-invasive application. However, the value of these new diagnostic tests to evaluate dysphagia and ICU-AW needs to be verified.
Read the detailed description
In this single-center observational study the investigators aim to evaluate neuromuscular ultrasound and blood biomarkers of neuromuscular damage as innovative diagnostic features for the detection, monitoring and prognostication of dysphagia and ICU-AW in critically ill patients. A detailed neurological examination, NMUS as well as blood biomarker measurements (e.g. Myl3, TNNI1, FABP-3) will be longitudinally performed at study day 1 (day of study inclusion), day 3, day 10 and day 17 after study inclusion. The neurological examination comprises the use of validated scales (GCS, RASS, mRS) and scores (MRC-ss) to assess consciousness, neurological disability and muscle strength as well as the the examination of the reflex status. Using a standardized in-house NMUS protocol the facial (masseter muscle), submental (digastricus muscle, mylohyoid muscle), cervical (sternocleidomastoid muscle) and extremity muscles (biceps brachii, brachiradialis, quadriceps femoris, tibialis anterior) as well as the vagus nerve will be assessed repeatedly. Additionally, a FEES as the current gold standard diagnostic for dysphagia will be performed at study day 10 or as soon as possible (depending on the ability of the patient to cooperate with the examiner) after study day 10 to detect and grade the dysphagia.
All study participants will be reevaluated at day 90 after study inclusion with regard to functional disability and survival.
Furthermore, healthy volunteers will be recruited and assessed in the same way as patients including a clinical examination, NMUS, laboratory testing and FEES.
The investigators hypothezise that:
- acquired dysphagia due to critical illness (not caused by central nervous system damage) is more likely in patients with ICU-AW
- the outcome in patients with a combination of ICU-AW and dysphagia is worse compared to patients with only one of these entities
- NMUS is able to detect and monitor dysphagia and ICU-AW in critically ill patients who are at risk of neuromuscular dysfunction
- specific blood biomarker levels correlate with the severity of neuromuscular impairment and are of value to identify patients with ICU-AW and acquired dysphagia
- Conditions
- Critical Illness, Dysphagia, Intensive Care Unit Acquired Weakness, Neuromuscular Diseases
- Medical subject headings
- Critical Illness, Deglutition Disorders, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia-positive | * critically ill patients more than 17 years of age * matching study inclusion criteria * confirmed newly acquired swallowing dysfunction using FEES at study day 10 or later * ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48) | |
| Dysphagia-negative | * critically ill patients more than 17 years of age * matching study inclusion criteria * newly acquired swallowing dysfunction ruled out using FEES at study day 10 or later * ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48) | |
| Controls | * healthy volunteers without any neuromuscular disease * swallowing dysfunction ruled out using FEES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sensomotory dysphagia in critically ill patients with and without intensive care unit-acquired weakness as well as controls
Assessment of dysphagia and ICU-AW using validated diagnostics (FEES, NMUS) and scores (MRC-ss)
Measured: Day 90
Changes in ultrasonographic parameters between patients with and without newly acquired sensomotory dysphagia as well as controls
NMUS protocol performed at study days 1, 3, 10 and 17
Measured: Change from baseline ultrasound parameters at day 17
Change in neuromuscular damage blood biomarker levels in critically ill patients with and without newly acquired sensomotory dysphagia as well as controls
Specific blood biomarker levels (e.g. TNNI1, FABP-3) measured at study days 1, 3, 10 and 17
Measured: Change from baseline parameters at day 17
Secondary outcomes (4)
Quality of life in patients with and without neuromuscular complications after hospital discharge
Assessment of the overall quality of life using validated tests [e.g. Modified Rankin Scale with a range from 0 (no symptoms) to 6 (dead)]
Measured: Day 90
Length of hospital stay comparing critically ill patients with and without neuromuscular complications
Cumulative days in hospital
Measured: 1 year
Survival in critically ill patients with and without neuromuscular complications
Survival after 28 days
Measured: Day 28
Survival in critically ill patients with and without neuromuscular complications
Survival after 90 days
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020
- Primary completion8 Dec 2024
- Study completion8 Dec 2024
Why it stopped: PI and the majority of the study team left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Johannes Ehler, MD, University of Rostock
- Investigators
- Felix Klawitter, MD, Principal investigator, University of RostockJohannes Ehler, MD, Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541602
- Sponsor's protocol ID
- NMCiCIP
- Acronym
- NMCiCIP
- Status last verified
- Dec 2024
- First submitted
- 1 Sep 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Neuromuscular Ultrasound and Blood Biomarkers for the Detection, Monitoring and Prognostication of Neuromuscular Complications in Critically Ill Patients: a Prospective Single-center Observational Study
- ClinicalTrials.gov ID
- NCT04541602
- Acronym / sponsor ID
- NMCiCIP / NMCiCIP
- Conditions
- Critical Illness, Dysphagia, Intensive Care Unit Acquired Weakness, Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI and the majority of the study team left institution.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 8 Dec 2024 (actual)
- First posted
- 9 Sep 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.
Dysphagia and the intensive care unit-acquired weakness (ICU-AW) are common and outcome-relevant neuromuscular complications in critically ill patients, especially after prolonged mechanical ventilation, sepsis and multi-organ failure. However, the impact of these two complications on the clinical course of critically ill patients needs further investigation.
Furthermore, the standard diagnostic procedure to detect and grade the acquired dysphagia using the fiberoptic endoscopic evaluation of swallowing (FEES) and the Medical Research Council sum score (MRC-ss) to detect ICU-AW are time-consuming and strongly dependent on patient compliance. An early and easy-to-use detection of these neuromuscular complications is currently difficult to be achieved in this patient population.
Neuromuscular ultrasound (NMUS) and the measurement of neuromuscular damage blood biomarkers became increasingly interesting for clinical researchers in the recent years due to their broad availability and their simple and non-invasive application. However, the value of these new diagnostic tests to evaluate dysphagia and ICU-AW needs to be verified.
Detailed description
In this single-center observational study the investigators aim to evaluate neuromuscular ultrasound and blood biomarkers of neuromuscular damage as innovative diagnostic features for the detection, monitoring and prognostication of dysphagia and ICU-AW in critically ill patients. A detailed neurological examination, NMUS as well as blood biomarker measurements (e.g. Myl3, TNNI1, FABP-3) will be longitudinally performed at study day 1 (day of study inclusion), day 3, day 10 and day 17 after study inclusion. The neurological examination comprises the use of validated scales (GCS, RASS, mRS) and scores (MRC-ss) to assess consciousness, neurological disability and muscle strength as well as the the examination of the reflex status. Using a standardized in-house NMUS protocol the facial (masseter muscle), submental (digastricus muscle, mylohyoid muscle), cervical (sternocleidomastoid muscle) and extremity muscles (biceps brachii, brachiradialis, quadriceps femoris, tibialis anterior) as well as the vagus nerve will be assessed repeatedly. Additionally, a FEES as the current gold standard diagnostic for dysphagia will be performed at study day 10 or as soon as possible (depending on the ability of the patient to cooperate with the examiner) after study day 10 to detect and grade the dysphagia.
All study participants will be reevaluated at day 90 after study inclusion with regard to functional disability and survival.
Furthermore, healthy volunteers will be recruited and assessed in the same way as patients including a clinical examination, NMUS, laboratory testing and FEES.
The investigators hypothezise that:
- acquired dysphagia due to critical illness (not caused by central nervous system damage) is more likely in patients with ICU-AW
- the outcome in patients with a combination of ICU-AW and dysphagia is worse compared to patients with only one of these entities
- NMUS is able to detect and monitor dysphagia and ICU-AW in critically ill patients who are at risk of neuromuscular dysfunction
- specific blood biomarker levels correlate with the severity of neuromuscular impairment and are of value to identify patients with ICU-AW and acquired dysphagia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dysphagia-positive | – | –* critically ill patients more than 17 years of age * matching study inclusion criteria * confirmed newly acquired swallowing dysfunction using FEES at study day 10 or later * ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48) |
| Dysphagia-negative | – | –* critically ill patients more than 17 years of age * matching study inclusion criteria * newly acquired swallowing dysfunction ruled out using FEES at study day 10 or later * ICU-AW positive (MRC-ss <48) or ICU-AW negative (MRC-ss ≥48) |
| Controls | – | –* healthy volunteers without any neuromuscular disease * swallowing dysfunction ruled out using FEES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the intensive care units of the study center will be screened for study eligibility according to the inclusion and exclusion criteria. Additionally, healthy volunteers will be recruited to participate as controls.
Key inclusion criteria (3 listed)
- adult patients above 17 years of age
- Sequential organ failure assessment (SOFA) score ≥8 within the first two days after ICU admission
- invasive mechanical ventilation ≥48 hours
Key exclusion criteria (7 listed)
- no written informed consent from patient or legal representative
- participation in another interventional study
- patient transfer from another hospital (>1 day hospital stay)
- preexisting swallowing disorder or disease of the larynx, pharynx or esophagus
- previous surgery of the larynx, pharynx, esophagus or maxillofacial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of sensomotory dysphagia in critically ill patients with and without intensive care unit-acquired weakness as well as controls
Time frame: Day 90
Assessment of dysphagia and ICU-AW using validated diagnostics (FEES, NMUS) and scores (MRC-ss)
Changes in ultrasonographic parameters between patients with and without newly acquired sensomotory dysphagia as well as controls
Time frame: Change from baseline ultrasound parameters at day 17
NMUS protocol performed at study days 1, 3, 10 and 17
Change in neuromuscular damage blood biomarker levels in critically ill patients with and without newly acquired sensomotory dysphagia as well as controls
Time frame: Change from baseline parameters at day 17
Specific blood biomarker levels (e.g. TNNI1, FABP-3) measured at study days 1, 3, 10 and 17
4 secondary outcomes
Quality of life in patients with and without neuromuscular complications after hospital discharge
Time frame: Day 90
Length of hospital stay comparing critically ill patients with and without neuromuscular complications
Time frame: 1 year
Survival in critically ill patients with and without neuromuscular complications
Time frame: Day 28
Survival in critically ill patients with and without neuromuscular complications
Time frame: Day 90
Results and safety
The study was stopped early (reason given: PI and the majority of the study team left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Felix Klawitter, MD principal investigator
University of Rostock
Johannes Ehler, MD principal investigator
University of Rostock
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 Critical Illness and Dysphagia, run by University of Rostock at 1 site in Germany.
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 7 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: stopped early, as of the sponsor's last update on 12 Dec 2024. 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 Germany. 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 was stopped early (reason given: PI and the majority of the study team left institution.). Results are not available in the source record.
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?
Incidence of sensomotory dysphagia in critically ill patients with and without intensive care unit-acquired weakness as well as controls (time frame: Day 90). The study lists 3 primary outcomes in all. 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 12 Dec 2024.