Respiratory InsufficiencyPhase 2ERNINCT01530282
Non-invasive Measurements of Elastance and Resistance
A Phase 2 study testing Invasive method and Non invasive method in people with Respiratory Insufficiency, run by University of Turin, Italy.
Trial summary
The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Invasive method and Non invasive method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intact respiratory drive;
- PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
- pH between 7.35 and 7.45;
- patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.
Who cannot join
- infection, sepsis or septic shock; (with fever no)
- hemodynamic instability;
- respiratory centres depression;
- esophageal deformity, or gastric/esophageal illnesses;
- previous recent gastric/esophageal surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.
- Conditions
- Respiratory Insufficiency
- Being tested
- Invasive method, Non invasive method
- Keywords
- Respiratory Insufficiency [C08.618.846]
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive methodOther
Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)
Non invasive methodOther
Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration
| Study group | Role | What they receive |
|---|---|---|
| measurement of respiratory mechanics | Experimental | Invasive method: two catheters will be inserted to measure reference respiratory mechanics Non_invasive method: airway pressure measured during a 150-200 ms occlusion at the beginning of inspiration. Receives: Other: Invasive method; Other: Non invasive method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive respiratory mechanics measurement
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
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
- 15 participants (estimated)
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
- Investigators
- Vito Marco VM RANIERI, MD, Principal investigator, Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530282
- Sponsor's protocol ID
- ERNI-0073496
- Acronym
- ERNI
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
- ClinicalTrials.gov ID
- NCT01530282
- Acronym / sponsor ID
- ERNI / ERNI-0073496
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory Insufficiency [C08.618.846]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 9 Feb 2012 (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 the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measurement of respiratory mechanics | Experimental | Other: Invasive method, Other: Non invasive methodInvasive method: two catheters will be inserted to measure reference respiratory mechanics Non_invasive method: airway pressure measured during a 150-200 ms occlusion at the beginning of inspiration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- intact respiratory drive;
- PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
- pH between 7.35 and 7.45;
- patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.
Key exclusion criteria (5 listed)
- infection, sepsis or septic shock; (with fever no)
- hemodynamic instability;
- respiratory centres depression;
- esophageal deformity, or gastric/esophageal illnesses;
- previous recent gastric/esophageal surgery.
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 |
|---|---|---|
| Invasive methodEsophageal and gastric catheters to measure respiratory mechanics (static and dynamic) | Other | measurement of respiratory mechanics |
| Non invasive methodNon_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration | Other | measurement of respiratory mechanics |
Primary outcome
Non-invasive respiratory mechanics measurement
Time frame: 2 hours
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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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.
Vito Marco VM RANIERI, MD principal investigator
Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Invasive method and Non invasive method in people with Respiratory Insufficiency, run by University of Turin, 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 4 inclusion and 5 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 9 Feb 2012. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vito Marco VM Ranieri, MD (+39 0116334001, marco.ranieri@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive respiratory mechanics measurement (time frame: 2 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 9 Feb 2012.