WeaningNCT01135121
Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
An observational study of Weaning and Respiratory Muscle Function, run by University Medical Center Nijmegen at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Respiratory Muscle Function
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2010to Jan 2016
- 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: ICU patients weaning from mechanical ventilation
Who may be able to join
- age > 18 year
- mechanical ventilation for at least 3 days
- the treating physician judges the patient to be ready to be weaned from the ventilator
- informed consent
Who cannot join
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
- upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- recent (< 1 month) nasal bleeding
- phrenic nerve lesions
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525GA
Leo Heunks, MD, PhD, +31 24 3617273, L.Heunks@ic.umcn.nl
Jonne Doorduin, Msc
About this study
Official title: Pilot Study on the Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.
- Conditions
- Weaning, Respiratory Muscle Function
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 |
|---|---|---|
| Weaning failure | Not described | |
| Weaning succes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatiguability of the diaphragm
Measured: Multiple measurements within 24 hours after start of weaning trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leo Heunks, University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135121
- Sponsor's protocol ID
- Wean1
- Status last verified
- Jun 2015
- First submitted
- 1 Jun 2010
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Role of Diaphragm Fatigue in Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01135121
- Acronym / sponsor ID
- Wean1
- Conditions
- Weaning, Respiratory Muscle Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 2 Jun 2010 (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.
The purpose of this study is to determine whether the diaphragm develops contractile fatigue during a weaning trial and if this is associated with weaning failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning failure | – | – |
| Weaning succes | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients weaning from mechanical ventilation
Key inclusion criteria (4 listed)
- age > 18 year
- mechanical ventilation for at least 3 days
- the treating physician judges the patient to be ready to be weaned from the ventilator
- informed consent
Key exclusion criteria (4 listed)
- pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases.
- upper airway / esophageal pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
- recent (< 1 month) nasal bleeding
- phrenic nerve lesions
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
Fatiguability of the diaphragm
Time frame: Multiple measurements within 24 hours after start of weaning trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
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 Weaning and Respiratory Muscle Function, run by University Medical Center Nijmegen 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 4 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: status not confirmed, as of the sponsor's last update on 10 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Heunks, MD, PhD (+31 24 3617273, L.Heunks@ic.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatiguability of the diaphragm (time frame: Multiple measurements within 24 hours after start of weaning trial). 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 Jun 2015.