Respiratory InsufficiencyPhase 2NCT01411722
Electrical Activity of the Diaphragm During the Weaning Period
A Phase 2 study testing Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter) in people with Respiratory Insufficiency, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2008to Jun 2012
- Phase
- Phase 2
- 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
Who may be able to join
- All patients older than 18 years and mechanically ventilated for >= 48 h.
- In the resolving stage of the disease which brought to mechanical ventilation.
- Pao2/Fio2 ratio >150 on positive end-expiratory pressure (PEEP) <=8 cm H2O.
- Sedation discontinued for a minimum of 24 hrs
- Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.
- Patient fully alert and cooperative.
- Intact respiratory drive evaluated with Glasgow Coma Scale >=10.
Who cannot join
- The attending physician refuses to allow enrolment
- The patient refuses informed consent
- Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine > 5 mcg/kg/min or norepinephrine > 0.1 mcg/kg/min to maintain systolic arterial blood pressure > 90 mmHg)
- No collaborative Patient
- Coagulation or platelets disorders
- neuromuscular disease
Show all 10Show fewer
- phrenic nerve damage/diaphragm paralysis
- contraindication to exchange naso-gastric tube
- History of heart or lung transplantation
- Presence or suspicion of a central nervous system disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period
The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome
Read the detailed description
Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.
- Conditions
- Respiratory Insufficiency
- Being tested
- Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
- Keywords
- Electrical Activity of Diaphragm, Weaning outcome, NAVA
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)Device
Nava is a new ventilatory mode which delivers pressure in proportion of the the Electrical activity of the diaphragm (EAdi), a reflection of the neural respiratory output. EAdi will be obtained through a nasogastric tube with a multiple array of electrodes placed at its distal end. Correct positioning of the EAdi catheter is assured by means of a specific function of the ventilator (''EAdi catheter positioning''). The EAdi signal is processed according to the American Thoracic Society (ATS) recommendations and filtered by algorithms designed to provide the highest possible signal-to-noise ratio
| Study group | Role | What they receive |
|---|---|---|
| EADIWEANING | Other | Patients mechanically ventilated for more than 48 hours during the weaning process. Receives: Device: Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical activity of the diaphragm as a predictor of weaning outcome
Measured: 48 hours
Secondary outcomes (2)
Comparison of electrical activity of the diaphragm as a predictor versus other predictors
Measured: 48 hours
Evaluation of respiratory parameters during the weaning process
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2008
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranieri, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411722
- Sponsor's protocol ID
- EADIWEANIG299
- Status last verified
- Jul 2013
- First submitted
- 5 Aug 2011
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period
- ClinicalTrials.gov ID
- NCT01411722
- Acronym / sponsor ID
- EADIWEANIG299
- Conditions
- Respiratory Insufficiency
- Keywords
- Electrical Activity of Diaphragm, Weaning outcome, NAVA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Aug 2011 (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 study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome
Detailed description
Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EADIWEANING | Other | Device: Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)Patients mechanically ventilated for more than 48 hours during the weaning process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients older than 18 years and mechanically ventilated for >= 48 h.
- In the resolving stage of the disease which brought to mechanical ventilation.
- Pao2/Fio2 ratio >150 on positive end-expiratory pressure (PEEP) <=8 cm H2O.
- Sedation discontinued for a minimum of 24 hrs
- Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.
Key exclusion criteria (10 listed)
- The attending physician refuses to allow enrolment
- The patient refuses informed consent
- Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine > 5 mcg/kg/min or norepinephrine > 0.1 mcg/kg/min to maintain systolic arterial blood pressure > 90 mmHg)
- No collaborative Patient
- Coagulation or platelets disorders
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 |
|---|---|---|
| Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)Nava is a new ventilatory mode which delivers pressure in proportion of the the Electrical activity of the diaphragm (EAdi), a reflection of the neural respiratory output. EAdi will be obtained through a nasogastric tube with a multiple array of electrodes placed at its distal end. Correct positioning of the EAdi catheter is assured by means of a specific function of the ventilator (''EAdi catheter positioning''). The EAdi signal is processed according to the American Thoracic Society (ATS) recommendations and filtered by algorithms designed to provide the highest possible signal-to-noise ratio | Device | EADIWEANING |
Primary outcome
Electrical activity of the diaphragm as a predictor of weaning outcome
Time frame: 48 hours
2 secondary outcomes
Comparison of electrical activity of the diaphragm as a predictor versus other predictors
Time frame: 48 hours
Evaluation of respiratory parameters during the weaning process
Time frame: 48 hours
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 1 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter) in people with Respiratory Insufficiency, run by University of Turin, Italy at 1 site in Italy.
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 7 inclusion and 10 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 1 Aug 2013. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Electrical activity of the diaphragm as a predictor of weaning outcome (time frame: 48 hours). 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 1 Aug 2013.