Respiratory FailureNCT01248845
Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance
A study testing Titration of various level of assistance in people with Respiratory Failure, run by Prof. Philippe Jolliet at 1 site in Switzerland.
Trial summary
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Titration of various level of assistance
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2010to Jun 2016
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the ICU, intubated for acute respiratory failure, and ventilated in PS mode will be eligible for inclusion in the study.
Who cannot join
- Severe hypoxemia requiring an FIO2 > 0.5
- hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-)
- oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery;
- active upper gastro-intestinal bleeding;
- known coagulation disorder;
- any other contraindication to the insertion of a naso-gastric tube;
- poor short term prognosis (death expected within the next seven days)
- age < 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance in Pressure Support and in Neurally Adjusted Ventilatory Assist
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
Read the detailed description
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
Aims of the study:
- To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in PS and in NAVA in intubated spontaneously breathing patients
- To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique
- Conditions
- Respiratory Failure
- Being tested
- Titration of various level of assistance
- Keywords
- Mechanical ventilation, Electrical diaphragmatic activity
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of various level of assistanceOther
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance
To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in Pressure and in Neurally adjusted ventilatory assist in intubated spontaneously breathing patients
Secondary outcomes (1)
Compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.
To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Difficulties to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Philippe Jolliet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Prof. Philippe Jolliet, University of Lausanne Hospitals
- Investigators
- Philippe Jolliet, Professor, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248845
- Sponsor's protocol ID
- EMG_titr
- Status last verified
- May 2017
- First submitted
- 20 Aug 2010
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance in Pressure Support and in Neurally Adjusted Ventilatory Assist
- ClinicalTrials.gov ID
- NCT01248845
- Acronym / sponsor ID
- EMG_titr
- Conditions
- Respiratory Failure
- Keywords
- Mechanical ventilation, Electrical diaphragmatic activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties to enroll patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Prof. Philippe JollietUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Aug 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Nov 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.
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
Detailed description
Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
Aims of the study:
- To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in PS and in NAVA in intubated spontaneously breathing patients
- To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique
Study design
- Primary purpose
- Supportive care
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the ICU, intubated for acute respiratory failure, and ventilated in PS mode will be eligible for inclusion in the study.
Key exclusion criteria (8 listed)
- Severe hypoxemia requiring an FIO2 > 0.5
- hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-)
- oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery;
- active upper gastro-intestinal bleeding;
- known coagulation disorder;
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 |
|---|---|---|
| Titration of various level of assistanceExploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded. | Other | – |
Primary outcome
Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance
To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in Pressure and in Neurally adjusted ventilatory assist in intubated spontaneously breathing patients
1 secondary outcome
Compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.
Results and safety
The study was stopped early (reason given: Difficulties to enroll patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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.
Philippe Jolliet, Professor principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of various level of assistance in people with Respiratory Failure, run by Prof. Philippe Jolliet at 1 site in Switzerland.
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 8 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 8 May 2017. 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 Switzerland. 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: Difficulties to enroll patients). 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?
Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance. 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 8 May 2017.