Respiratory FailureInterThickNCT05990348
Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA
An observational study of Respiratory Failure and Weaning Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Weaning Failure
- What is being tested?
- difficult weaning patients
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 30 Sep 2025
- 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: Critically ill patients on mechanical ventilation (MV) for at least 24 hours, who have failed at least one weaning attempt, hospitalized at the Intensive Care Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS.
Who may be able to join
- patients who have failed at least one weaning attempt
- mechanical ventilation for at least 24 hours
Who cannot join
- Pregnancy
- Obesity (Body Mass Index > 35 kg/m2)
- Contraindication to the insert of a nasogastric tube
- Neuromuscular diseases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Giorgia Spinazzola
Rome, 00168
giorgia spinazzola, +393297813925, giorgia.spinazzola@policlinicogemelli.it
About this study
the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) . Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
Read the detailed description
Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from mechanical ventilation (MV) in critically ill patients. Muscular activity is important during the inspiratory phase of ventilation, which is mainly due to diaphragm and external intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and ranges from 33 to 95% . Although several indexes have been investigated to help clinician in identifying its disturbance, their clinical value is controversial . External intercostal muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to investigate such condition. However, the echography assessment of intercostal muscles thickening fraction (TFic) has shown promising results in this field as a non-invasive tool to assess inspiratory muscle function and predict weaning failure .
On the other hand, the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests that EAdi and derived parameters, may be helpful to predict weaning failure in chronic obstructive pulmonary disease (COPD) patients .
However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory effort parameters and the occurrence of respiratory asynchrony in patients with difficult weaning from MV admitted in ICU.
- Conditions
- Respiratory Failure, Weaning Failure
- Being tested
- difficult weaning patients
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
difficult weaning patientsOther
intercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
What is being measured
The primary outcome is the main question the study is designed to answer.
intercostal thickening fraction
intercostal thickening fraction values during PSV and NAVA
Measured: From date of enrollment until the date of extubation (up to seven days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jul 2022
- Primary completion30 May 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SPINAZZOLA GIORGIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990348
- Sponsor's protocol ID
- 4856
- Acronym
- InterThick
- Status last verified
- Oct 2024
- First submitted
- 24 Feb 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will assess the availability of data based on the results
Publications
Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.
PubMed 30904733Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
PubMed 27677861Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
PubMed 32516052Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
PubMed 25879592
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Diaphragm Electrical Activity and Intercostal Thickening Fraction During Different Pattern of Mechanical Ventilation: PSV Versus NAVA
- ClinicalTrials.gov ID
- NCT05990348
- Acronym / sponsor ID
- InterThick / 4856
- Conditions
- Respiratory Failure, Weaning Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- 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 introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) . Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive. However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
Detailed description
Respiratory muscles dysfunction is one of the main causes leading to failure of weaning from mechanical ventilation (MV) in critically ill patients. Muscular activity is important during the inspiratory phase of ventilation, which is mainly due to diaphragm and external intercostal muscles. Diaphragm dysfunction is frequent among critically ill patients and ranges from 33 to 95% . Although several indexes have been investigated to help clinician in identifying its disturbance, their clinical value is controversial . External intercostal muscles dysfunction epidemiology is unknown because of lack of non-invasive tool to investigate such condition. However, the echography assessment of intercostal muscles thickening fraction (TFic) has shown promising results in this field as a non-invasive tool to assess inspiratory muscle function and predict weaning failure .
On the other hand, the introduction of new MV modalities has shown promising results in reducing the incidence of weaning failure, mainly due to a more physiologic approach which allows respiratory muscle preservation. Among them, the Neurally Adjust Ventilatory Assist (NAVA) seemed to be associated with lower incidence of weaning failure and subsequent duration of mechanical ventilation, compared to standard modalities like the Pressure Support Ventilation (PSV) [. Moreover, NAVA allows the evaluation of the diaphragm electrical activity (EAdi), an index of diaphragmatic neural respiratory drive . A recent study suggests that EAdi and derived parameters, may be helpful to predict weaning failure in chronic obstructive pulmonary disease (COPD) patients .
However, no study has compared TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU.
the aim of this study will be the comparison of TFic values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU and the assessment of the inspiratory effort parameters and the occurrence of respiratory asynchrony in patients with difficult weaning from MV admitted in ICU.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients on mechanical ventilation (MV) for at least 24 hours, who have failed at least one weaning attempt, hospitalized at the Intensive Care Unit of Fondazione Policlinico Universitario A. Gemelli IRCCS.
Key inclusion criteria (2 listed)
- patients who have failed at least one weaning attempt
- mechanical ventilation for at least 24 hours
Key exclusion criteria (4 listed)
- Pregnancy
- Obesity (Body Mass Index > 35 kg/m2)
- Contraindication to the insert of a nasogastric tube
- Neuromuscular diseases
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 |
|---|---|---|
| difficult weaning patientsintercostal thickening fraction values during PSV and NAVA modalities in patients with difficult weaning from MV admitted in ICU. | Other | – |
Primary outcome
intercostal thickening fraction
Time frame: From date of enrollment until the date of extubation (up to seven days)
intercostal thickening fraction values during PSV and NAVA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Results publication: PubMed 30904733Abdelwahed WM, Abd Elghafar MS, Amr YM, Alsherif SEI, Eltomey MA. Prospective study: Diaphragmatic thickness as a predictor index for weaning from mechanical ventilation. J Crit Care. 2019 Aug;52:10-15. doi: 10.1016/j.jcrc.2019.03.006. Epub 2019 Mar 15. No abstract available.
- Results publication: PubMed 27677861Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.
- Results publication: PubMed 32516052Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
- Results publication: PubMed 25879592Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
- Individual participant dataSharing planned: Undecided. We will assess the availability of data based on the results
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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.
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 Respiratory Failure and Weaning Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 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 18 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact giorgia GS spinazzola, md (0630154507, giorgia.spinazzola@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intercostal thickening fraction (time frame: From date of enrollment until the date of extubation (up to seven days)). 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 NCT05990348, which also lists 4 linked publications.
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 18 Oct 2024.