Postoperative PatientsNAVANCT03027713
Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)
A study testing weaning protocol in people with Postoperative Patients, run by Fundación para la Investigación del Hospital Clínico de Valencia.
Trial summary
The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Patients
- What is being tested?
- weaning protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.
Who cannot join
- Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.
About this study
Official title: Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.
The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients
Read the detailed description
We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups
- Conditions
- Postoperative Patients
- Being tested
- weaning protocol
- Keywords
- NAVA: neurally adjusted ventilatory assist, Diaphragm electromyographic activity, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaning protocolProcedure or surgery
The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
| Study group | Role | What they receive |
|---|---|---|
| NAVA group with a specific catheter | Other | The patients were allocated in the NAVA weaning protocol group Receives: Procedure: weaning protocol |
| PSV group without a specific catheter | Other | The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group Receives: Procedure: weaning protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic electromyographic activity description
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PatientsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F Javier Belda, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Mar Garzando Civera, M.D., Ph.D., Principal investigator, Fundación para la investigación del Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027713
- Sponsor's protocol ID
- dawNAVA
- Acronym
- NAVA
- Status last verified
- Jan 2017
- First submitted
- 4 Sep 2016
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared data will be anonymous
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.
- ClinicalTrials.gov ID
- NCT03027713
- Acronym / sponsor ID
- NAVA / dawNAVA
- Conditions
- Postoperative Patients
- Keywords
- NAVA: neurally adjusted ventilatory assist, Diaphragm electromyographic activity, Weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2017 (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 describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients
Detailed description
We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA group with a specific catheter | Other | Procedure: weaning protocolThe patients were allocated in the NAVA weaning protocol group |
| PSV group without a specific catheter | Other | Procedure: weaning protocolThe patients were allocated in the PSV (pressure-support ventilation) weaning protocol group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.
Key exclusion criteria (1 listed)
- Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.
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 |
|---|---|---|
| weaning protocolThe patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group | Procedure or surgery | NAVA group with a specific catheter, PSV group without a specific catheter |
Primary outcome
Diaphragmatic electromyographic activity description
Time frame: 1 hour
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 23 Jan 2017.
- Individual participant dataSharing planned: Yes. Shared data will be anonymous
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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.
Mar Garzando Civera, M.D., Ph.D. principal investigator
Fundación para la investigación del Hospital Clínico Universitario de Valencia
Questions about this trial
What is this clinical trial studying?
A study testing weaning protocol in people with Postoperative Patients, run by Fundación para la Investigación del Hospital Clínico de Valencia.
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 1 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Diaphragmatic electromyographic activity description (time frame: 1 hour). 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 23 Jan 2017.