Respiratory Distress Syndrome, AdultOLDIANCT04520815
Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
An observational study of Respiratory Distress Syndrome, Adult, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2020to 21 Dec 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Recruitment of all patients over the age of 75, presenting to adult emergency departments and in spontaneous ventilation and having at least one criterion of acute respiratory distress.
Who may be able to join
- Patient in spontaneous ventilation at the admission on emergency room
- Presence of acute respiratory distress defined by at least 1 of the following criteria:
- Respiratory rate > 25/min and/or clinical signs of acute respiratory distress,
- Hypoxia defined by Sp02 < 90 %,
- Hypercapnia defined by PaC02 > 45 mmHg with respiratory acidosis defined by a pH value <7.35.
- Absence of opposition of the patient to his participation in the study and the use of his data or the trusted person if the state of the patient does not allow it.
Who cannot join
- Presence of a preexisting diaphragmatic dysfunction appearing in the history or the medical file of the patient and explored on the electro-physiological level,
- Patient with acute respiratory distress on arrival at the SAU with clinical criteria justifying immediate use of invasive mechanical ventilation and not allowing ultrasound measurements to be carried out or patient admitted to the SAU with mechanical ventilatory support from the outset,
- Poor command of the French language or state incompatible with the patient's understanding and / or informed adherence to the study protocol,
- History of surgery involving the integrity of the diaphragmatic muscle (diaphragm plication or diaphragmatic lumpectomy or placement of diaphragmatic pacemaker),
- Criteria for shock or severe hemodynamic instability,
- Intra-cranial hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.> 75 years) admitted to the emergency reception service are multiple.
To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.
- Conditions
- Respiratory Distress Syndrome, Adult
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: inclusion
Presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 1
Presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 3
Presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 7
Presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: up to 7 days
Secondary outcomes (13)
Inter-observer reproductibility of the measurement of ED and EIT
Comparison of the measure in the between two operators
Measured: Day 0
Predictive value of the presence of diaphragmatic dysfunction
Ultrasound measurement of diaphragmatic excursion (ED) on the use of ventilatory assistance
Measured: 48 hours after the beginning of hospitalization
Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay
length of hospitalization duration in Intensive care unit
Measured: up to 7 days
Predictive value of the presence of a diaphragmatic dysfunction on mortality
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: up to 7 days
Predictive value of the presence of a diaphragmatic dysfunction on mortality
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: 6 months after the end of hospitalization
Kinetics of evolution of the diaphragmatic function
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 1
Kinetics of evolution of the diaphragmatic function
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 3
Evolution of the diaphragmatic function
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Day 7
Evolution of the diaphragmatic function
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: Before 7 days
Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD)
Identification of the risk factors and Ultrasound measurement of diaphragmatic excursion (ED)
Measured: up to 7 days
Possible correlation between the presence of a DD diagnosed by the ultrasound measurement of the ED and the duration of mechanical ventilation, the duration of hospitalization in ICU, respiratory complications rate and failures organs rate
qSOFA et APACHE II score
Measured: up to 7 days
Correlation between the presence of DD diagnosed by ultrasound measurement of ED and the evolution of the functional status of the patient at the end of hospitalization compared to his status at the admission
scores ADL et AGGIR
Measured: up to 7 days
Presence of diaphragmatic dysfunction in patients with COVID-19
Ultrasound measurement of diaphragmatic excursion (ED)
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start24 Jun 2020
- Primary completion21 Jun 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- Other
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas GROSEIL, Dr, Principal investigator, CHU de La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520815
- Sponsor's protocol ID
- 2020/CHU/10
- Acronym
- OLDIA
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2020
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
- ClinicalTrials.gov ID
- NCT04520815
- Acronym / sponsor ID
- OLDIA / 2020/CHU/10
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 20 Aug 2020 (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.
Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.> 75 years) admitted to the emergency reception service are multiple.
To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Recruitment of all patients over the age of 75, presenting to adult emergency departments and in spontaneous ventilation and having at least one criterion of acute respiratory distress.
Key inclusion criteria (6 listed)
- Patient in spontaneous ventilation at the admission on emergency room
- Presence of acute respiratory distress defined by at least 1 of the following criteria:
- Absence of opposition of the patient to his participation in the study and the use of his data or the trusted person if the state of the patient does not allow it.
Key exclusion criteria (6 listed)
- Presence of a preexisting diaphragmatic dysfunction appearing in the history or the medical file of the patient and explored on the electro-physiological level,
- Patient with acute respiratory distress on arrival at the SAU with clinical criteria justifying immediate use of invasive mechanical ventilation and not allowing ultrasound measurements to be carried out or patient admitted to the SAU with mechanical ventilatory support from the outset,
- Poor command of the French language or state incompatible with the patient's understanding and / or informed adherence to the study protocol,
- History of surgery involving the integrity of the diaphragmatic muscle (diaphragm plication or diaphragmatic lumpectomy or placement of diaphragmatic pacemaker),
- Criteria for shock or 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.
Primary outcome
Presence of diaphragmatic dysfunction
Time frame: inclusion
Ultrasound measurement of diaphragmatic excursion (ED)
Presence of diaphragmatic dysfunction
Time frame: Day 1
Ultrasound measurement of diaphragmatic excursion (ED)
Presence of diaphragmatic dysfunction
Time frame: Day 3
Ultrasound measurement of diaphragmatic excursion (ED)
Presence of diaphragmatic dysfunction
Time frame: Day 7
Ultrasound measurement of diaphragmatic excursion (ED)
Presence of diaphragmatic dysfunction
Time frame: up to 7 days
Ultrasound measurement of diaphragmatic excursion (ED)
13 secondary outcomes
Inter-observer reproductibility of the measurement of ED and EIT
Time frame: Day 0
Predictive value of the presence of diaphragmatic dysfunction
Time frame: 48 hours after the beginning of hospitalization
Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay
Time frame: up to 7 days
Predictive value of the presence of a diaphragmatic dysfunction on mortality
Time frame: up to 7 days
Predictive value of the presence of a diaphragmatic dysfunction on mortality
Time frame: 6 months after the end of hospitalization
Kinetics of evolution of the diaphragmatic function
Time frame: Day 1
Kinetics of evolution of the diaphragmatic function
Time frame: Day 3
Evolution of the diaphragmatic function
Time frame: Day 7
Evolution of the diaphragmatic function
Time frame: Before 7 days
Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD)
Time frame: up to 7 days
Possible correlation between the presence of a DD diagnosed by the ultrasound measurement of the ED and the duration of mechanical ventilation, the duration of hospitalization in ICU, respiratory complications rate and failures organs rate
Time frame: up to 7 days
Correlation between the presence of DD diagnosed by ultrasound measurement of ED and the evolution of the functional status of the patient at the end of hospitalization compared to his status at the admission
Time frame: up to 7 days
Presence of diaphragmatic dysfunction in patients with COVID-19
Time frame: up to 7 days
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Thomas GROSEIL, Dr principal investigator
CHU de La Réunion
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 Distress Syndrome, Adult, run by Centre Hospitalier Universitaire de la Réunion 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 6 inclusion and 6 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 11 Sep 2026. 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?
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?
Presence of diaphragmatic dysfunction (time frame: inclusion). The study lists 5 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 11 Sep 2026.