Diaphragm DysfunctionRHYDIANNCT03852394
Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed NIV (RHYDIAN)
An observational study of Diaphragm Dysfunction and COPD Exacerbation, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Dysfunction, COPD Exacerbation, Mechanical Ventilation
- What is being tested?
- Respiratory mechanics assessment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 1 Mar 2022
- 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: Cohort study
Who may be able to join
- age over 18 years
- AECOPD with respiratory acidosis admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena (Italy) undergoing endotracheal intubation due to NIV failure.
Who cannot join
- history of neuromuscular disease,
- presence of chest wall deformities,
- coexistence of interstitial lung disease,
- presence of pulmonary edema,
- severe hemodynamic instability,
- septic shock,
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- evidence of lobar pneumonia or bilateral parenchymal consolidation at chest X-ray on admission,
- contraindication to NIV,
- previously assessed diaphragmatic palsy,
- intracranial hypertension,
- known pregnancy,
- need for immediate endotracheal intubation,
- neurologic impairment,
- lack of collaboration,
- unreliable maneuver to calculate maximal transdiaphragmatic pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed Non-invasive Mechanical Ventilation
Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Recent studies have shown that the onset of severe diaphragmatic dysfunction (DD) during AECOPD increases risk of NIV failure and mortality in this subset of patients. Although the imbalance between the load and the contractile capacity of inspiratory muscles seems the main cause of AECOPD-induced hypercapnic respiratory failure, data regarding the influence of mechanical derangement on diaphragmatic performance in this acute phase are lacking. With this study we aim at investigating the impact of respiratory mechanics on diaphragm function in AECOPD patients who experienced NIV failure. AECOPD with respiratory acidosis admitted to the ICU of the University Hospital of Modena from 2017-2018 undergoing mechanical ventilation (MV) due to NIV failure were enrolled. The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.
- Being tested
- Respiratory mechanics assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory mechanics assessmentOther
The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of static elastance on diaphragm function in AECOPD patient who failed NIV
Correlation between static elastance and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD
Measured: 30 days from Respiratory Intensive Care Unit admission
Impact of dynamic intrinsic Positive End Expiratory Pressure on diaphragm function in AECOPD patient who failed NIV
Correlation between dynamic intrinsic Positive End Expiratory Pressure and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD
Measured: 30 days from Respiratory Intensive Care Unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852394
- Sponsor's protocol ID
- UModenaReggio 4
- Acronym
- RHYDIAN
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed Non-invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03852394
- Acronym / sponsor ID
- RHYDIAN / UModenaReggio 4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Feb 2019 (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.
Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Recent studies have shown that the onset of severe diaphragmatic dysfunction (DD) during AECOPD increases risk of NIV failure and mortality in this subset of patients. Although the imbalance between the load and the contractile capacity of inspiratory muscles seems the main cause of AECOPD-induced hypercapnic respiratory failure, data regarding the influence of mechanical derangement on diaphragmatic performance in this acute phase are lacking. With this study we aim at investigating the impact of respiratory mechanics on diaphragm function in AECOPD patients who experienced NIV failure. AECOPD with respiratory acidosis admitted to the ICU of the University Hospital of Modena from 2017-2018 undergoing mechanical ventilation (MV) due to NIV failure were enrolled. The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort study
Key inclusion criteria (2 listed)
- age over 18 years
- AECOPD with respiratory acidosis admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena (Italy) undergoing endotracheal intubation due to NIV failure.
Key exclusion criteria (15 listed)
- history of neuromuscular disease,
- presence of chest wall deformities,
- coexistence of interstitial lung disease,
- presence of pulmonary edema,
- severe 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 |
|---|---|---|
| Respiratory mechanics assessmentThe study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi. | Other | – |
Primary outcome
Impact of static elastance on diaphragm function in AECOPD patient who failed NIV
Time frame: 30 days from Respiratory Intensive Care Unit admission
Correlation between static elastance and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD
Impact of dynamic intrinsic Positive End Expiratory Pressure on diaphragm function in AECOPD patient who failed NIV
Time frame: 30 days from Respiratory Intensive Care Unit admission
Correlation between dynamic intrinsic Positive End Expiratory Pressure and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD
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 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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 Diaphragm Dysfunction and COPD Exacerbation, run by University of Modena and Reggio Emilia 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 15 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 7 Apr 2022. 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?
Impact of static elastance on diaphragm function in AECOPD patient who failed NIV (time frame: 30 days from Respiratory Intensive Care Unit admission). The study lists 2 primary outcomes in all. 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 7 Apr 2022.