PEEP, IntrinsicechoPEEPiNCT02388282
A New Method for Estimating Dynamic Intrinsic PEEP
An observational study of PEEP, Intrinsic and PEEP, Occult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Dinamic intrinsic PEEP is Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PEEP, Intrinsic, PEEP, Occult, Respiratory Insufficiency
- What is being tested?
- diaphragm ecography
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Nov 2015
- 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: Patients with both acute or chronic respiratory insufficiency, who required respiratory mechanics measurements for clinical purpose.
Who may be able to join
- Acute or chronic respiratory failure
- Age >=18 y
Who cannot join
- Lack of informed consent
- Controindication to the placement of oesophageal and gastric catheter:
- esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.
- Cardiac arrest
- Severe emodinamic instability (> 1 vasoacttive drug)
- Acute coronary syndrome (AMI/UA)
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- Inability to protect airway
- Respiratory arrest
- Pregnancy suspected or confirmed
- Diaphragm palsy
- Curarization in the preceding five hours
- Mechanical ventilation in controlled mode.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Method for Estimating Dynamic Positive End-expiratory Pressure. Description and Validation With PEEPi Dyn Measured With Transdiaphragmatic Pressure
Dinamic intrinsic PEEP is
Read the detailed description
Dynamic intrinsic positive end-expiratory pressure (PEEPi dyn) play an important pathophysiology role in many acute respiratory pathologies.
The most accurate method to quantify PEEPi dyn is to measure the rise in transdiaphragmatic pressure (Pdi) at end expiration at the point of the contraction of the inspiratory muscles until inspiratory flow starts.
Such method, however, is invasive, poor comfortable and require patient active collaboration.
The purpose of this study is describe a new non-invasive method for estimate PEEPi dyn and validate this method with gold-standard-one.
- Conditions
- PEEP, Intrinsic, PEEP, Occult, Respiratory Insufficiency
- Being tested
- diaphragm ecography
- Keywords
- dynamic intrinsic PEEP, diaphragm echography, respiratory mechanics
- Medical subject headings
- Positive-Pressure Respiration, Intrinsic, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm ecographyDevice
recording of diaphragm ecography
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.
Measured: 20 minutes
Secondary outcomes (2)
Correlation and agreement between neural inspiratory time and ecographic inspiratory time
Measured: 10 minutes
Inter-rater agreement to assest method reliability
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PEEP, IntrinsicStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388282
- Sponsor's protocol ID
- 7/2015/O/Sper
- Acronym
- echoPEEPi
- Status last verified
- Aug 2015
- First submitted
- 9 Mar 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bernardi E, Pisani L, Fasano L, Lauria G, Comellini V, Appendini L, Conti G, Tosello F, Pizzolato E, Nava S. A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):392-396. doi: 10.1164/rccm.201706-1292LE. No abstract available.
PubMed 29558160
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Estimating Dynamic Positive End-expiratory Pressure. Description and Validation With PEEPi Dyn Measured With Transdiaphragmatic Pressure
- ClinicalTrials.gov ID
- NCT02388282
- Acronym / sponsor ID
- echoPEEPi / 7/2015/O/Sper
- Conditions
- PEEP, Intrinsic, PEEP, Occult, Respiratory Insufficiency
- Keywords
- dynamic intrinsic PEEP, diaphragm echography, respiratory mechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Mar 2015 (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.
Dinamic intrinsic PEEP is
Detailed description
Dynamic intrinsic positive end-expiratory pressure (PEEPi dyn) play an important pathophysiology role in many acute respiratory pathologies.
The most accurate method to quantify PEEPi dyn is to measure the rise in transdiaphragmatic pressure (Pdi) at end expiration at the point of the contraction of the inspiratory muscles until inspiratory flow starts.
Such method, however, is invasive, poor comfortable and require patient active collaboration.
The purpose of this study is describe a new non-invasive method for estimate PEEPi dyn and validate this method with gold-standard-one.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with both acute or chronic respiratory insufficiency, who required respiratory mechanics measurements for clinical purpose.
Key inclusion criteria (2 listed)
- Acute or chronic respiratory failure
- Age >=18 y
Key exclusion criteria (12 listed)
- Lack of informed consent
- Controindication to the placement of oesophageal and gastric catheter:
- esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.
- Cardiac arrest
- Severe emodinamic instability (> 1 vasoacttive drug)
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 |
|---|---|---|
| diaphragm ecographyrecording of diaphragm ecography | Device | – |
Primary outcome
Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.
Time frame: 20 minutes
2 secondary outcomes
Correlation and agreement between neural inspiratory time and ecographic inspiratory time
Time frame: 10 minutes
Inter-rater agreement to assest method reliability
Time frame: 10 minutes
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 29 Dec 2015.
- Derived from this study: PubMed 29558160Bernardi E, Pisani L, Fasano L, Lauria G, Comellini V, Appendini L, Conti G, Tosello F, Pizzolato E, Nava S. A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):392-396. doi: 10.1164/rccm.201706-1292LE. No abstract available.
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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?
An observational study of PEEP, Intrinsic and PEEP, Occult, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 2 inclusion and 12 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 29 Dec 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 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.
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?
Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388282, which also lists 1 linked publication.
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 29 Dec 2015; AzTrials last refreshed its copy on 27 Oct 2026.