Diaphragm DysfunctionPRODIGYNCT06420999
Incidence and Impact of ICU-acquired Diaphragm Weakness
An observational study of Diaphragm Dysfunction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Dysfunction
- What is being tested?
- Diaphragmatic ultrasound and data collection
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2024to 29 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The eligible population will be that of adult patients who have been in intensive care and have received invasive mechanical ventilation for at least 48 hours or non-invasive ventilation or humidified high-flow oxygen therapy for at least 48 hours, with a PaO2/FiO2 ratio < 200 before ventilatory support was introduced.
Who may be able to join
- Age ≥ 18 years
- Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.
- Weaning from respiratory support (invasive or not) within the last 24 hours.
- Patient (or trusted person/relative) informed and not opposed to the study.
Who cannot join
- Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)
- Patients with tracheostomy
- Non-communicating patients
- Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Médecine intensive Réanimation
Paris, 75013
Martin DRES, MD, PhD, 0142167809, martin.dres@aphp.fr
About this study
ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge.
The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days.
Read the detailed description
Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.
ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest.
Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.
- Conditions
- Diaphragm Dysfunction
- Being tested
- Diaphragmatic ultrasound and data collection
- Keywords
- ICU, diaphragmatic activity, Respiratory support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic ultrasound and data collectionOther
At the inclusion visit, anamnestic data available in the medical record and clinical data (vitals, chest X-ray) will be collected. At the same time, a diaphragmatic ultrasound will be performed in the half-seated position to measure diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm at rest. A follow-up visit will be made on the day of discharge from intensive care, during which diaphragmatic ultrasound will be performed At D90 (+/- 15 days), the following information will be collected by consulting the electronic medical record, or by telephone if the information is not available in the record: date of discharge from hospital, date of death, date and reason for readmission to hospital or intensive care, possible introduction of long-term non-invasive ventilation, new respiratory complication after discharge from intensive care (pneumonia, atelectasis).
| Study group | Role | What they receive |
|---|---|---|
| Patients weaned from mechanical or non invasive ventilation | Adults admitted to ICU receiving either invasive mechanical ventilation for at least 48 hours, non-invasive ventilation or high-flow humidified oxygen therapy for at least 48 hours, and who have been weaned from ventilatory support within the last 24 hours. Receives: Other: Diaphragmatic ultrasound and data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90
Mortality
Measured: 90 days after inclusion (+/- 15 days)
Secondary outcomes (7)
Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).
Measurement of dyspnea on day of discharge from intensive care, assessed by visual analog scale (VAS). Scale of 1 to 10 with 10 corresponding to minimal comfort
Measured: The day of discharge from ICU
Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.
Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.
Measured: The day of discharge from ICU
Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.
Clinically significant dyspnea defined by a VAS>3/10. Scale of 1 to 10 with 10 corresponding to minimal comfort
Measured: The day of discharge from ICU
Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.
Length of hospital stay
Measured: 90 days after inclusion (+/- 15 days)
Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.
Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction<20%.
Measured: On the day ventilation is weaned
Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions
Percentage of readmissions to intensive care and hospital at D90.
Measured: 90 days after inclusion (+/- 15 days)
Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.
The percentage of respiratory complications at D90, defined by the occurrence of pneumonia, reintubation, atelectasis (or worsening in case of pre-existing abnormality).
Measured: 90 days after inclusion (+/- 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start29 Jul 2024
- Primary completion29 Jan 2028 (estimated)
- Study completion29 Jan 2028 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420999
- Sponsor's protocol ID
- APHP240248
- Acronym
- PRODIGY
- Status last verified
- May 2025
- First submitted
- 15 May 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Impact of ICU-acquired Diaphragm Weakness
- ClinicalTrials.gov ID
- NCT06420999
- Acronym / sponsor ID
- PRODIGY / APHP240248
- Conditions
- Diaphragm Dysfunction
- Keywords
- ICU, diaphragmatic activity, Respiratory support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 29 Jan 2028 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 20 May 2024 (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.
ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge.
The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days.
Detailed description
Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.
ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest.
Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients weaned from mechanical or non invasive ventilation | – | Other: Diaphragmatic ultrasound and data collectionAdults admitted to ICU receiving either invasive mechanical ventilation for at least 48 hours, non-invasive ventilation or high-flow humidified oxygen therapy for at least 48 hours, and who have been weaned from ventilatory support within the last 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible population will be that of adult patients who have been in intensive care and have received invasive mechanical ventilation for at least 48 hours or non-invasive ventilation or humidified high-flow oxygen therapy for at least 48 hours, with a PaO2/FiO2 ratio < 200 before ventilatory support was introduced.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.
- Weaning from respiratory support (invasive or not) within the last 24 hours.
- Patient (or trusted person/relative) informed and not opposed to the study.
Key exclusion criteria (4 listed)
- Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)
- Patients with tracheostomy
- Non-communicating patients
- Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).
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 |
|---|---|---|
| Diaphragmatic ultrasound and data collectionAt the inclusion visit, anamnestic data available in the medical record and clinical data (vitals, chest X-ray) will be collected. At the same time, a diaphragmatic ultrasound will be performed in the half-seated position to measure diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm at rest. A follow-up visit will be made on the day of discharge from intensive care, during which diaphragmatic ultrasound will be performed At D90 (+/- 15 days), the following information will be collected by consulting the electronic medical record, or by telephone if the information is not available in the record: date of discharge from hospital, date of death, date and reason for readmission to hospital or intensive care, possible introduction of long-term non-invasive ventilation, new respiratory complication after discharge from intensive care (pneumonia, atelectasis). | Other | Patients weaned from mechanical or non invasive ventilation |
Primary outcome
Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90
Time frame: 90 days after inclusion (+/- 15 days)
Mortality
7 secondary outcomes
Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality).
Time frame: The day of discharge from ICU
Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care.
Time frame: The day of discharge from ICU
Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care.
Time frame: The day of discharge from ICU
Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay.
Time frame: 90 days after inclusion (+/- 15 days)
Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay.
Time frame: On the day ventilation is weaned
Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions
Time frame: 90 days after inclusion (+/- 15 days)
Association between diaphragmatic dysfunction and the risk of respiratory complications at D90.
Time frame: 90 days after inclusion (+/- 15 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Related trials for Diaphragm Dysfunction
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
Recruiting
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
Ventilator Induced Diaphragm Dysfunction
Recruiting
Shenfu Injection for the Prevention and Treatment of Ventilator Dependence in Mechanically Ventilated Patients
Ventilator-induced Diaphragm Dysfunction, Ventilator Dependence
Recruiting
Effects of Inspiratory Muscle Training and Positive Expiratory Pressure on Mechanically Ventilated Restrictive Lung Disease Patients
Restrictive Lung Diseases
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.
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, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Dres, MD,PHD (0142167809, martin.dres@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90 (time frame: 90 days after inclusion (+/- 15 days)). 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 28 May 2025.